3ibiomet

Surgical ManualCertain® Internal Connection And External ConnectionImplant Systems

Certain InternalConnection Implants

ExternalConnection Implants

CATSM

Global Headquarters4555 Riverside DrivePalm Beach Gardens, FL 334101-800-342-5454Outside The U.S.: +1-561-776-6700Fax: +1-561-776-1272www.biomet3i.com

ACT, Bone Bonding, CAM StructSURE, Certain, DIEM, Encode, EP, GingiHue, Gold-Tite, IOL, Miniplant, OSSEOTITE, OSSEOTITE XP, PreFormance,PREVAIL, Provide, QuickBridge, QuickSeat, STA and ZiReal are registered trademarks and ICE, MicroMiniplant, NanoTite and No-Touch are trademarks ofBIOMET 3i LLC. BIOMET is a registered trademark and BIOMET 3i and design are trademarks of BIOMET, Inc. ©2008 BIOMET 3i LLC. All rights reserved.

REV F 08/08

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NOTESIcon Key:

Certain Internal ConnectionImplant System:

External ConnectionImplant System:

Certain Internal Connectionand External ConnectionImplant System:

How To Use The Icon Key:

The icons represent the connection types of theBIOMET 3i Implant System and both internal andexternal connection types are represented in thismanual. In the fully illustrated protocols, each iconis present by each step. When a dark burgundy iconand a light burgundy icon are present together, thedark burgundy indicates which system is illustrated.When both icons are dark burgundy, then bothsystems are illustrated together.

Instructions For Use:

OSSEOTITE®, OSSEOTITE XP®, Certain®, PREVAIL®, Encode®, IOL®, Miniplant®,Microminiplant™, GingiHue®, Gold-Tite®, Provide®, STA®, ZiReal®, CAMStructSURE®, NanoTite™, PreFormance®, QuickBridge®

This document applies to dental implants, abutments, overdenture bars and associatedsurgical, restorative and dental laboratory components.

For detailed information on the specific procedure for the product you are using, please referto the individual product labels and/or the appropriate manual:

Product Catalog - CATALOG: Listing of all productsSurgical Manual - CATSM: Dental implant placement, surgical protocol and cover screw

insertionRestorative Manual - CATRM: Abutment placement, provisional and final

restoration protocolsAdditional Restorative Manuals:

CAM StructSURE Manual - ART868 DIEM® Guidelines - ART860Encode Restorative Manual - ART924 QuickBridge Manual - ART1016

Description: BIOMET 3i Dental Implants are manufactured from biocompatible titanium andtitanium alloy and abutments from titanium, titanium alloy, gold alloy and ceramic material.BIOMET 3i Dental Implants and Abutments include various surface treatments and coatings.Other restorative components are manufactured with titanium, titanium alloy, gold alloy,stainless steel and a variety of polymers.

For specific product description and net quantity refer to individual product labels.

Indications for Use: BIOMET 3i Dental Implants are intended for surgical placement in theupper or lower jaw to provide a means for prosthetic attachment in single tooth restorationsand in partially or fully edentulous spans with multiple single teeth utilizing delayed orimmediate loading, or as a terminal or intermediary abutment for fixed or removablebridgework and to retain overdentures.

BIOMET 3i OSSEOTITE and NanoTite Dental Implants are intended for immediate function onsingle tooth and/or multiple tooth applications when good primary stability is achieved, withappropriate occlusal loading, in order to restore chewing function.

Additional Indications: BIOMET 3i Dental Abutments and Overdenture Bars are intended foruse as an accessory to endosseous dental implants to support a prosthetic device in apartially or edentulous patient. These are intended for use to support single and multipletooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement-retained to the abutment.

PEEK Abutment Posts and Temporary Cylinders are intended for use as an accessory toendosseous dental implants to support a prosthetic device in a partially or fully edentulouspatient. These are intended for use to support single and multiple unit prostheses in themandible or maxilla for up to 180 days during endosseous and gingival healing and are fornon-occlusal loading of single and multiple unit provisional restorations. The prostheses canbe screw and/or cement-retained to the abutment. These Temporary Posts and Cylindersrequire a minimum interarch space of 6mm and a maximum angulation of 15°. These alsoallow for occlusal loading of single and multiple unit restorations of integrated implants forguided soft tissue healing.

The QuickBridge Provisional Components are intended to be mated with BIOMET 3i ConicalAbutments for use as an accessory to endosseous dental implants to support a prostheticdevice in a partially or fully edentulous patient. The QuickBridge Provisional Components areintended to support multiple unit prostheses in the mandible or maxilla for up to 180 daysduring endosseous and gingival healing.

Contraindication: Placement of dental implants may be precluded by patient conditions thatare contraindications for surgery. BIOMET 3i Dental Implants should not be placed in patientswhere the remaining jaw bone is too diminished to provide adequate implant stability.

Storage and Handling: Devices should be stored at room temperature. Refer to individualproduct labels and the Surgical Manual for special storage or handling conditions.

Warnings: Excessive bone loss or breakage of a dental implant or restorative device mayoccur when an implant or abutment is loaded beyond its functional capability. Physiologicaland anatomic conditions may negatively affect the performance of dental implants.

The following should be taken into consideration when placing dental implants:• Poor bone quality• Poor oral hygiene• Medical conditions such as blood disorders or uncontrolled hormonal conditions

It is recommended that small diameter implants not be restored with angled abutments inthe molar region.

Mishandling of small components inside the patient’s mouth carries a risk of aspirationand/or swallowing.

Forcing the implant into the osteotomy deeper than the depth established by the drills canresult in: stripping the driver hex interface inside the implant, stripping the driver, cold-welding of the mount-driver interface to the implant or stripping the walls of the osteotomythat may prevent an effective initial implant fixation.

Clinical data have demonstrated enhanced performance of OSSEOTITE Implants ascompared to other BIOMET 3i Dental Implants in patients with poor quality bone.

Precautions: For safe and effective use of BIOMET 3i Dental Implants, abutments and othersurgical and restorative dental accessories, these products or devices should only be used bytrained professionals. The surgical and restorative techniques required to properly utilizethese devices are highly specialized and complex procedures. Improper technique can lead toimplant failure, loss of supporting bone, restoration fracture, screw loosening and aspiration.

Sterility: All dental implants and some abutments are supplied sterile and are sterilized byan appropriate validated method. Refer to individual product labels for sterilizationinformation; all sterile products are labeled ‘STERILE.’ All products sold sterile are for singleuse before the expiration date printed on the product label. Do not use sterile products if thepackaging has been damaged or previously opened. Do not re-sterilize or autoclave exceptwhere instructions to do so are provided on the product label, in the Surgical Manual, in theRestorative Manual or in any additional marketing literature for that product. Productsprovided non-sterile must be cleaned and sterilized according to the directions found inART630 or the Surgical Manual prior to use.

Procedural Precautions, Surgery: For a detailed explanation of the procedural precautionsrefer to the Surgical Manual. During the planning phase, it is important to determine thevertical dimension, the actual space available between the alveolar crest and the opposingdentition, in order to confirm that the available space will accommodate the proposedabutment and the final crown restoration. This information varies with each patient andabutment; therefore it should be carefully evaluated before placing any dental implant.The final prosthesis should be designed prior to the placement of the dental implant.Utilize continuous irrigation with a cool, sterile irrigating solution to avoid excessive damageto the surrounding tissue and to prevent compromising osseointegration. This is mandatoryduring all procedures. Avoid excessive pressure during preparation of the bone site. As thedrilling speed varies based on the instrument and the surgical procedure, recommendationsfor speed can be found in the Surgical Manual. Only sharp instruments of the highest qualityshould be used for any surgical procedure involving bone. Minimizing trauma to the boneand surrounding tissue enhances the potential for successful osseointegration. In order toeliminate contaminants and other sources of infection, all non-sterile devices should becleaned and/or sterilized prior to use, per the instructions on the individual product labels.

Procedural Precautions, Restoration: The healing period varies depending on the quality ofthe bone at the implantation site, the tissue response to the implanted device and thesurgeon’s evaluation of the patient’s bone density at the time of the surgical procedure.Excessive force applied to the dental implant should be avoided during the healing period.Proper occlusion should be evaluated on the implant restoration to avoid excessive force.

Potential Adverse Events: Potential adverse events associated with the use of dentalimplants may include:

Caution: U.S. Federal Law restricts this device to sale by or on the order of a licenseddentist or physician.

• Failure to integrate• Loss of integration• Dehiscence requiring bone grafting• Perforation of the maxillary sinus,

inferior border, lingual plate, labial plate,inferior alveolar canal, gingiva

• Infection as reported by: abscess,fistula, suppuration, inflammation,radiolucency

• Persistent pain, numbness, paresthesia• Hyperplasia• Excessive bone loss requiring

intervention• Implant breakage or fracture• Systemic infection• Nerve injury

Table Of Contents

Introduction And Treatment Planning . . . . . . . . . . . . . . . . 1

Preoperative Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Top-Down Treatment Planning . . . . . . . . . . . . . . . . . . . . . . 3

Surgical Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Cleaning And Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Twist Drill Depth Marking System . . . . . . . . . . . . . . . . . . . 6

Mountless Delivery Guidelines ForCertain® Internal Connection Implants . . . . . . . . . . . . . . . 11

Bone Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Surgical Indexing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Single-Stage Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

PARALLEL WALLED IMPLANTS

Countersink Drill Marking System . . . . . . . . . . . . . . . . . . 12

Parallel Walled Implant Surgical Tray . . . . . . . . . . . . . . 13

Bone Density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Certain PREVAIL® Platform Switching ImplantsQuick Reference Surgical ProtocolCertain PREVAIL 3/4/3mm Diameter Implant . . . . . . . . . . . . 15Certain PREVAIL 4/3mm Diameter Implant. . . . . . . . . . . . . . 17Certain PREVAIL 4/5/4mm Diameter Implant . . . . . . . . . . . . 18Certain PREVAIL 5/4mm Diameter Implant. . . . . . . . . . . . . . 18Certain PREVAIL 5/6/5mm Diameter Implant . . . . . . . . . . . . 19

Subcrestal Surgical ProtocolCertain PREVAIL 3/4/3mm Diameter Implant . . . . . . . . . . . . 22Certain PREVAIL 4/3mm Diameter Implant. . . . . . . . . . . . . . 28Certain PREVAIL 4/5/4mm Diameter Implant . . . . . . . . . . . . 30Certain PREVAIL 5/4mm Diameter Implant. . . . . . . . . . . . . . 33Certain PREVAIL 5/6/5mm Diameter Implant . . . . . . . . . . . . 35

Subcrestal Stepped Surgical Protocol . . . . . . . . . . . . . . . . . 41

Subcrestal Implant Placement ProtocolCertain Internal Connection And External Connection Implants . 42

Certain Internal Connection ImplantsQuick Reference Surgical ProtocolCertain MicroMiniplant™ 3.25mm Diameter Implant . . . . . . 15Certain 4mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . 17XP Certain 4/5mm Diameter Implant . . . . . . . . . . . . . . . . . . . 18

Certain 5mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . 18XP Certain 5/6mm Diameter Implant. . . . . . . . . . . . . . . . . . . 19Certain 6mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . 19

Subcrestal Surgical ProtocolCertain MicroMiniplant 3.25mm Diameter Implant . . . . . . . . 20Certain 4mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . 28XP Certain 4/5mm Diameter Implant. . . . . . . . . . . . . . . . . . . 30Certain 5mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . 33XP Certain 5/6mm Diameter Implant. . . . . . . . . . . . . . . . . . . 35Certain 6mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . 38


Subcrestal Implant Placement ProtocolCertain Internal Connection And External Connection Implants. . 42

External Connection ImplantsQuick Reference Surgical ProtocolMicroMiniplant 3.25mm Diameter Implant . . . . . . . . . . . . . . 15XP 3/4mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . 163.75mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . . . 164mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17XP 4/5mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . 185mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18XP 5/6mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . 196mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Subcrestal Surgical ProtocolMicroMiniplant 3.25mm Diameter Implant. . . . . . . . . . . . . . . 20XP 3/4mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . 243.75mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . . . 264mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28XP 4/5mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . 305mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33XP 5/6mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . 356mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38


Subcrestal Implant Placement ProtocolCertain Internal Connection And External Connection Implants. . 42

Tapered Implants continued on the next page

CATSM-F_Surgical_Manual:Layout 1 8/15/08 11:02 AM Page a

Table Of Contents (Continued)

TAPERED IMPLANTS

Proper Subcrestal Placement Of Tapered Implants . . . 45

Quad Shaping Drill (QSD) For BIOMET 3iTapered Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Tapered Implant Depth/Direction Indicator (NTDI). . . . 47

Tapered Implant Bone Taps And Bone Tap Kit (NTAPK) . . 48

Tapered Implant Surgical Tray (QNTSK) . . . . . . . . . . . . . 49

Tapered Certain® PREVAIL® Platform Switching ImplantsQuick Reference Surgical ProtocolTapered Certain PREVAIL 4/3mm Diameter Implant . . . . . . . 50Tapered Certain PREVAIL 5/4mm Diameter Implant . . . . . . . 51Tapered Certain PREVAIL 6/5mm Diameter Implant . . . . . . . 51

Subcrestal Surgical ProtocolTapered Certain PREVAIL 4/3mm Diameter Implant . . . . . . . 54Tapered Certain PREVAIL 5/4mm Diameter Implant . . . . . . . 57Tapered Certain PREVAIL 6/5mm Diameter Implant . . . . . . . 60

Subcrestal Implant Placement ProtocolTapered Certain Internal Connection AndTapered External Connection Implants . . . . . . . . . . . . . . . . . 63

Subcrestal Stepped Surgical ProtocolTapered Certain Internal Connection And Tapered ExternalConnection 4mm, 5mm And 6mm Diameter Implants . . . . . 66

Tapered Certain Internal Connection ImplantsQuick Reference Surgical ProtocolTapered Certain MicroMiniplant™ 3.25mm Diameter Implant. . 50Tapered Certain 4mm Diameter Implant . . . . . . . . . . . . . . . . 50Tapered Certain 5mm Diameter Implant . . . . . . . . . . . . . . . . 51Tapered Certain 6mm Diameter Implant . . . . . . . . . . . . . . . . 51

Subcrestal Surgical ProtocolTapered Certain MicroMiniplant 3.25mm Diameter Implant . . 52Tapered Certain 4mm Diameter Implant . . . . . . . . . . . . . . . . 54Tapered Certain 5mm Diameter Implant . . . . . . . . . . . . . . . . 57Tapered Certain 6mm Diameter Implant . . . . . . . . . . . . . . . . 60



Tapered External Connection ImplantsQuick Reference Surgical ProtocolTapered MicroMiniplant 3.25mm Diameter Implant . . . . . . . 50Tapered 4mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . 50Tapered 5mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . 51Tapered 6mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . 51

Subcrestal Surgical ProtocolTapered MicroMiniplant 3.25mm Diameter Implant . . . . . . . 52Tapered 4mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . 54Tapered 5mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . 57Tapered 6mm Diameter Implant . . . . . . . . . . . . . . . . . . . . . . 60



CATSM-F_Surgical_Manual:Layout 1 8/15/08 11:02 AM Page b

1

These instructions were designed to serve as a reference

guide for dental practitioners to utilize BIOMET 3i Implants

and surgical instruments to their maximum potential.

BIOMET 3i’s Implant System was developed to meet the

diverse needs of patients and to offer practitioners a choice

of surgical techniques customized to meet each patient’s

individual requirements.

BIOMET 3i’s Unique Designs enable the practitioner to place

implants in edentulous or partially edentulous mandibles or

maxillae in order to support fixed and removable bridgework

or single tooth crowns and to provide the stabilization

needed for retaining overdentures. BIOMET 3i’s System uses

proven surgical procedures to properly secure the implant

into bone, thus achieving the physiological phenomenon

referred to as osseointegration.

With NanoTite™ Implants, the combined microtopography of

the OSSEOTITE® Implant with the nanometer-scale architecture

created with the NanoTite Surface treatment renders the

surface Bone Bonding® by the interlocking of the newly formed

cement line matrix of bone with the implant surface.

General Information:

These instructions will instruct practitioners in the use

of BIOMET 3i’s Implant Systems. The success of any dental

implant system depends upon proper use of the components

and instrumentation. This manual is not intended for use as a

substitute for professional training and experience.

Treatment Planning:

Patient Evaluation And Selection

Several important factors must be considered when

evaluating a patient prior to implant surgery. The presurgical

evaluation must include a cautious and detailed assessment

of the patient’s general health, current medical status,

medical history, oral hygiene, motivation and expectations.

Factors such as heavy tobacco use, chewing patterns and

alcohol consumption should also be considered. In addition,

the clinician should determine if the case presents an

acceptable anatomical basis conducive to implant placement.

An extensive intraoral examination should be undertaken to

evaluate the oral cavity for any potential bone or soft-tissue

pathology. The examiner should also determine the perio-

dontal status of the remaining teeth, the health of the soft

tissue, or the presence of occlusal abnormalities such as

bruxism or crossbite. The presence of other conditions

that could adversely affect any existing natural dentition

or healthy tissue surrounding the implant should also

be evaluated.

Diseases of the mucous membrane and connective tissues,

pathologic bone disease and severe malocclusion could

affect the determination of whether a patient is a suitable

implant candidate.

The use of anticoagulants and the existence of metabolic

diseases, such as diabetes, allergies, chronic renal or cardiac

disease and blood dyscrasia could significantly influence the

patient’s ability to successfully undergo implant procedures.

If the patient’s medical history reveals an existing condition

or signals a potential problem that may compromise treat-

ment and/or the patient’s well-being, consultation with a

physician is recommended.

Introduction AndTreatment Planning

CATSM-F_Surgical_Manual:Layout 1 8/15/08 11:02 AM Page 1

2

Preoperative Planning

Radiographic Marking Balls (RMB30)

The vertical height of the bone can be determined radiographi-

cally. Accurate measurement of the vertical dimension on the

radiograph facilitates the selection of the appropriate implant

length. This helps to avoid implant placement into the maxillary

sinus, the floor of the nose or the mandibular canal and prevents

perforation of the inferior aspect of the mandible. Measurements

can be made directly on the panoramic radiograph using a mil-

limeter ruler. Corrections should be made for the degree of

enlargement produced by the particular radiographic equipment.

Radiographic marking balls of a known dimension can be

embedded in a plastic template prior to radiographic examina-

tion. Once the radiograph is taken and the metal marking balls

are visible on the image, measurements can be taken to deter-

mine the amount of bone available for implant placement.

To calculate the distortion factor, a simple formula can be

utilized: (5 ÷ A) x B = amount of actual bone available.

Formula Key =

• Radiographic marking ball = 5mm in diameter.

• A = Size of marking ball image on radiograph.

• B = Length in millimeters on the radiograph of available

bone between the crest of the ridge and the inferior

alveolar canal.

Example:

A = 6.5mm

B = 14mm

Therefore: (5 ÷ 6.5) x 14 = 10.76mm actual bone available

NOTE: A 2mm margin of safety, from the apical end of

the implant to the adjacent vital structure, should

be considered.

Preoperative Planning:

Proper treatment planning, as well as the selection of the

proper implant length and diameter, are crucial to the long-

term success of the implant and restoration. Before an

implant can be selected, the anatomical foundation available

to receive the implant must be carefully assessed. Several

steps should be taken to complete the evaluation:

1. Clinical examination of the oral cavity can provide

important information about the health of the soft tissue

at the proposed implant site. Tissue tone and the state of

the superficial tissues should be evaluated. In addition,

the patient should demonstrate an adequate dimension of

attached gingiva or keratinized tissue at the site selected

for implantation. In partially edentulous cases, the peri-

odontal status of the remaining dentition should be

assessed and interaction between the implant restoration

and the adjacent natural dentition should be considered.

2. The bony foundation and ridge need to be clinically ana-

lyzed to ensure the presence of proper dimensions and

the amount of bone for implant placement. At least one

millimeter of bone should be present at the buccal and

lingual aspects of the implant following placement.

During the planning state, it is useful to measure the

existing bone foundation.

CT Scans:

Computed tomography (CT) scans help surgeons view

parts of the body with three-dimensional images.

Image-guided surgical planning allows surgeons to see

anatomical landmarks such as nerves, sinus cavities and

bony structures in order to plan for the placement of dental

implants and prostheses.

Through the use of CT scans, clinicians are able to more

precisely measure the locations of anatomical structures,

dimensions of the underlying bone and ascertain bone

densities in order to plan and treat clinically

demanding cases.Inferior AlveolarNerve Canal

Marking Ball Image(6.5mm on this radiograph)

A

B


3

7.5

3.54

5.5 5

8 9 5 5.55

8 58 5

In its simplest form, top-down treatment planning refers to a

protocol whereby the desired restorative result is considered

first, leading to consideration of the appropriate prosthetic

platform and subsequent implant selection based on bony

anatomy and the size of the missing tooth.

A top-down treatment planning methodology will provide

maximum biomechanical stability and allow for soft tissue

flaring by utilizing an implant with a prosthetic platform

slightly smaller in diameter than the emergence diameter of

the tooth being replaced. BIOMET 3i’s wide selection of

implants allows clinicians to match the size of the prosthetic

platform to the restoration it will eventually support, while

allowing for different bone volumes and anatomical features

at the implant site. Implant and healing abutment selections

are based upon the relationship of several key measurements:

• The emerging dimension of the crown in relation to

the diameter of the prosthetic platform of the implant

• The height and diameter of the intended restoration

at the tissue exit point

• The bone volume at the implant site in relation to the

diameter of the implant body

The Emergence Profile (EP®) Healing Abutment System

consists of healing abutments of various diameters and

heights for shaping the soft tissue to replicate the geometry

and gingival contours of natural dentition.

Top-DownTreatment Planning

5/6mm 6mm 4mm 4mm 5mm

5/6mm 6mm 4/3mm 5mm 4/5mm 3.25/4mm

CrownDiameter

ImplantDiameter

3/4/3mm 5/6/5mm

3.25mm

Implants depicted arerepresentative of thebreadth of BIOMET 3iImplant products.


Clinical Considerations

True bone contours can only be evaluated after tissue flaps

have been reflected at the time of surgery or via preoperative

high quality CT scans. Even if bone dimensions are painstak-

ingly measured prior to surgery, the doctor and patient must

accept the possibility that inadequate bone anatomy might be

discovered during surgery and preclude implant placement.

During the presurgical planning phase, it is important to

determine the interocclusal clearance - the actual space

available between the alveolar crest and the opposing

dentition - to confirm that the available space will

accommodate the proposed abutment and the final crown

restoration. The height required by the abutment may vary

with the type of abutment; therefore, the surgeon and

restorative dentist should carefully evaluate the abutment

size. The final prosthesis should be conceptually designed

prior to the placement of the implant.

Diagnostic casts can be used preoperatively to evaluate the

residual ridge and to determine the position and angulation

of all implants. These casts allow the clinician to evaluate the

opposing dentition and its effect on the implant position. A

surgical guide stent, which is critical for determining the

precise position and angulation of the implant, can be

constructed on the diagnostic cast.

Several software companies offer planning software that

allows clinicians to plan implant placement three

dimensionally in conjunction with the CT scans. From plans

created in these software packages, surgical guides can be

made to aid in the preangulation and placement of implants.

To prevent damage to the bone tissue and to prevent

compromising osseointegration, abundant and continuous

irrigation with a cool, sterile, irrigating solution is mandatory

during all drilling procedures.

Bone surgery utilizes a high-torque electric drilling unit

that can be operated in forward and reverse modes at speeds

ranging from 0 to 1500rpm, depending on the surgical

requirements. Sharp instruments of the highest quality

should be utilized during implant site preparation to reduce

possible overheating and trauma to the bone. Minimizing

trauma enhances the potential for successful osseointegration.

The time elapsed between surgical placement of the implant

and final abutment placement can vary or be modified,

depending on the quality of the bone at the implantation site,

bony response to the implant surface and other implanted

materials and the surgeon’s assessment of the patient’s bone

density at the time of the surgical procedure. Extreme care

must be taken to avoid excessive force being applied to the

implant during this time.

4

Surgical Precautions


5

Single use drills/burs are supplied sterile and should beproperly disposed of after each procedure. Reusabledrills/burs and instrumentation are supplied nonsterile andmust be sterilized prior to use. Nonsterile items must beremoved from the packaging before sterilization.

Multiple sterilizations may affect the flow of fluid throughinternally irrigated drills. The drills should be inspectedfollowing each sterilization cycle to determine if fluid flowsthrough the irrigation ports. Although the surgical drills areconstructed of stainless steel, these should be adequatelydried prior to packaging for sterilization and again after thesterilization cycle. Reusable drills are recommended to bereplaced after 15 osteotomy preparations, subject to theinformation below.

The end of life for surgical instruments is normallydetermined by wear and damage. Surgical instruments andinstrument cases are susceptible to damage for a variety ofreasons including prolonged use, misuse, rough or improperhandling. Care must be taken to avoid compromising theintended performance of the instrument.

Visually inspect each instrument before and after each use fordamage and/or wear.

To extend the useful life of BIOMET 3i’s Instruments, certainprocedures should always be followed:

Cleaning:1. After use, place drills into a beaker of plain water, mild

soap or specialized cleaning solution.

2. Rinse with tap water for a minimum of two minuteswhile brushing with a soft bristled brush to removevisible debris. Clean the interior lumen with a thin wire toremove any remaining debris.

3. Place instruments in an ultrasonic bath containingenzymatic detergent for five minutes.* Scrub theinstruments again with a soft bristled brush and reamthe interior lumen to remove any remaining debris.

4. Rinse and flush the instruments for one minute using tapwater.

5. Inspect visually for any remaining bone fragments ordebris and scrub as necessary.

Sterilization:6. Remove the bur block from the surgical tray. Scrub the

surgical tray and block with a soft bristled brush andmild soap. Rinse thoroughly.

7. Place the components into the surgical tray and pourethyl alcohol (do not use rubbing alcohol) over the bursand tray to remove soap residue and minerals from thewater. This step is important to help prevent corrosionand spotting. Let the components dry before wrapping.

8. Wrap the surgical tray in paper or autoclave-approvedbags twice to prevent a tear of the outer packaging fromcontaminated instruments.

9. Steam gravity sterilize for forty minutes at a temperatureof 270–̊275˚F (132–̊135˚C).

10. Dry for 30 minutes. Drying times may vary according toload size.

Notes:1. Multiple sterilizations may affect the flow of fluid through

internally irrigated burs. After each use, ream the bursindividually with wire to remove any bone fragments ordebris that will prevent the flow of water. This is doneprior to the sterilization cycle.

2. Do not remove drills, instrumentation or the surgical trayfrom the autoclave until the “dry cycle” is complete.Very Important!

3. These guidelines DO NOT apply to the cleaning andsterilization of your powered instrumentation. Pleasefollow your powered instrumentation manufacturer’sinstructions.

Please refer to ART630 for complete instructions on thesterilization and care of stainless steel.

*ENZOL enzymatic detergent was used to validate this process, per the manufacturer’sdilution recommendation.

Cleaning And Sterilization


6

Twist Drill Depth Marking System

The BIOMET 3i Depth Marks measurement system provides amark on the drill that corresponds to the placement of theimplant via well-established procedures. BIOMET 3i’s OriginalProtocol follows the principles of protecting the implant frompremature loading by placing the implant subcrestally.

NOTE: A drill extension for areas of limited access is available.

Drill DiameterITD/DTN/DT

Drill Tip LengthACT®

Drill Tip Length2.00mm 0.6mm 0.6mm2.30mm 0.7mm N/A2.75mm 0.8mm 0.9mm3.00mm 0.9mm 0.9mm3.15mm 1.0mm 1.0mm3.25mm 1.0mm 1.0mm3.85mm N/A 1.2mm4.25mm 0.4mm 1.3mm4.85mm N/A 1.3mm5.25mm 0.5mm 1.2mm

The length of the drill tip is not included in the depthmark measurement. The drill tip length should beconsidered when preparing the osteotomy.

The length of the drill tip varies with the diameter ofthe drill.

The drill depth marks do not indicate implant lengths.Rather, the marks represent the length of the implantwith the cover screw in place. As a result, to place animplant and cover screw subcrestally requires drillingto the middle of the single line depth mark or thebeginning or end of the broad band depth mark onACT Drills. For crestal placement, drill halfway beforethe corresponding depth mark for the implant length.For supracrestal placement, the drill depth markshould remain above the bone by 1mm for the coverscrew plus the implant collar height. Refer to thediagram on the bottom of page 10 for moreinformation.

Drilling Depth

The drilling depth with the Twist Drill will varydepending on the type of placement related to thebone crest.

The depth marks are specific for subcrestal implantplacement only. There are no specific depth markson the drills for crestal or supracrestal placement.

Traditional Subcrestal Protocol

Implant Anatomy

Collar Height 1.25mm (Collar H) .75mm (Std. Collar H) Collar Height

External Connection

BIOMET 3iExternal Connection

ACT3015

Certain Internal Connection External Connection

ACT3015

2mmTwist Drill

Depth Gauge Implant WithCover Screw

Implant Platform Implant Platform

1-Subcrestal2-Crestal

3-Supracrestal

11.5mmImplant

Drill Tip Max 1.3mm

11.5mmImplant

Drill Tip Max 1.3mm

1-Subcrestal2-Crestal3-Supracrestal

BIOMET 3iCertain®

Internal Connection

MajorDiameter

MajorDiameter

MinorDiameter

MinorDiameter


7

ITD Reusable Drills

• Internal Irrigation Lumen• All Thin Lines

Types Of Twist Drills

DTN Disposable Drills

• Without Internal Irrigation Lumen• Bands

ACT Drill Marks

8.5mm

7mm

Drill Tip

10mm

11.5mm

13mm

15mm

Max 1.3mm

The length of the drill tip is notincluded in the depth markmeasurement. The drill tiplength should be consideredwhen preparing the osteotomy.

The length of the drill tip varieswith the diameter of the drill.

The center of the drill’s singleline depth marks and thebeginning or end of the broadband indicates subcrestalplacement for the correspon-ding length implant. Drill Tip Dimensions

PREVAIL®, Certain® Internal Connection, External Connection

Drill Marks And ImplantsThe standard cover screws are1mm in height for both CertainInternal Connection andExternal Connection implants.

1mm

IIOS4511 IOSS411 OSS411 OS4511Certain Internal Connection

Regardless of the implant type, thelength of the implant is the same fromthe top of the implant collar (platform),to the tip of the implant.

IIOS4511 IOSS411 OSS411 OS4511Certain Internal Connection External Connection

The depth marks on the drill representimplant placement where the top of the

cover screw (when height of thecover screw is 1mm) is flush withthe crest of the bone (subcrestal).

ACT® Reusable Drills

• No Hub• Without Internal Irrigation• Alternating Lines And Bands

External Connection

Twist Drill Depth Marking System (Continued)

Drill DiameterITD/DTN/DT

Drill Tip LengthACT

Drill Tip Length2.00mm 0.6mm 0.6mm2.30mm 0.7mm N/A2.75mm 0.8mm 0.9mm3.00mm 0.9mm 0.9mm3.15mm 1.0mm 1.0mm3.25mm 1.0mm 1.0mm3.85mm N/A 1.2mm4.25mm 0.4mm 1.3mm4.85mm N/A 1.3mm5.25mm 0.5mm 1.2mm


8

Labeled vs. Actual Lengths

9.1mm

7.6mm

10.6mm

12.1mm

13.6mm

15.6mm

LabeledLengths

ACT3015

The center of the drill’ssingle line depth marks andthe beginning or end of thebroad band indicate the lengthof the implant with a standardcover screw in place.

Drill TipMax 1.3mm

1mm

The actual implant lengths from the top of the implantcollar (platform) to the tip of the implant are shorterby 0.4mm than the labeled length.

The landmarks (grooves) on the CertainImplant Driver Tip and the External ConnectionImplant Mount act as references duringimplant placement.

ExternalConnection

CertainInternal

Connection

CertainInternal

Connection

External Connection

Actual Implant LengthsWith Cover Screw ON

15mm

13mm

11.5mm

10mm

8.5mm

7mm

LabeledLengths

Actual Implant LengthsWith Cover Screw OFF

15mm

13mm

10mm

8.5mm

7mm

Certain®

InternalConnection


*From point on drill at which maximum diameter starts. (Drill depth mark is .5mm wide) Drill length listed in chart does not include drill tip.

NOTE: A 2mm margin of safety from the apical end of the implant to the adjacent vital structure should be considered.

N/A N/A 7.0mm 6.6mm 1.0mm 7.6mm8.5mm 8.1mm 8.5mm 8.1mm 1.0mm 9.1mm

10.0mm 9.6mm 10.0mm 9.6mm 1.0mm 10.7mm11.5mm 11.1mm 11.5mm 11.1mm 1.0mm 12.1mm13.0mm 12.6mm 13.0mm 12.6mm 1.0mm 13.7mm15.0mm 14.6mm 15.0mm 14.6mm 1.0mm 15.7mm

N/A N/A 18.0mm 17.6mm 1.0mm 18.7mmN/A N/A 20.0mm 19.6mm 1.0mm 20.7mm

12.6mm

14.6mm

8.1mm

6.6mm

9.6mm

11.1mm11.5mm

ExternalConnection

TaperedImplant Length

(Label)

Actual TaperedImplant Length

Parallel WalledImplant Length

(Label)

Actual ParallelWalled Implant

Length

Cover ScrewHeight

Actual Drill LengthTo Subcrestal Mark


9

11.5mm implants

Subcrestal

Drill Tip Max 1.3mm

8.5mm7mm

10mm

Crestal Placement

Subcrestal Placement

• The implant platform will be 1mm (or more) below the bone crest.• Mostly used in the anterior region for aesthetics.

Drill Tip Max 1.3mm

8.5mm7mm

1mm

11.5mm implants

Subcrestal

10mm

• The implant platform will be at the bone crest.

11.5mm implants

Crestal

Drill Tip Max 1.3mm

8.5mm7mm

11.5mm

Drill Tip Max 1.3mm

8.5mm7mm

11.5mm

11.5mm implants

Crestal

10mm 1mm

1mm

Certain® Internal Connection External Connection

Certain Internal Connection External Connection


Bone Crest Bone Crest

10mm

11.5mm11.5mm

Bone Crest Bone Crest

For subcrestal Certain Internal Connection and ExternalConnection implant placement, drill to the drill depth markthat corresponds to the labeled implant length.

A Countersink Drill is used when placing a 4mm diameterimplant subcrestally to prepare the bone to accept the coverscrew. Remember, for a 4mm diameter implant, the implantplatform is 4.1mm in diameter and the cover screw flares to4.5mm in diameter.

1mm

A Countersink Drill is generally not needed becausethe cover screw for the 4mm diameter implant willstay above the bone crest. It may be needed in densebone due to the shape of the implant collar.

For crestal Certain Internal Connection and External Connectionimplant placement, stop drilling 1mm before the drill depthmark that corresponds to the labeled implant length (1mmequals cover screw height).


Subcrestal Crestal

11.5mm Certain Internal Connection ImplantsDrill Tip max 1.3mm

10

11.5mm implants

Supracrestal

Drill Tip max 1.3mm

8.5mm7mm

10mm

Supracrestal Placement

11.5mm

8.5mm7mm

11.5mm10mm 0.75mm collar H

Drill Tip max 1.3mm

8.5mm7mm

11.5mm

11.5mm implants

Supracrestal

10mm

Drill Tip max 1.3mm

For supracrestal Certain Internal Connection Implantplacement, stop drilling 2.25mm before the drill depth markthat corresponds to the labeled implant length (2.25mm equals1mm cover screw height plus 1.25mm Certain InternalConnection Implant collar height).

For supracrestal External Connection Implant placement, stopdrilling 1.75mm before the drill depth mark that corresponds to thelabeled implant length (1.75mm equals 1mm cover screw heightplus 0.75mm External Connection standard implant collar height).

• The height of the implant platform above the bonevaries with the specific implant type being placed.

Implant Type Collar Height

MicroMiniplant™ Implants 1.50mm

Certain Internal Connection Implants 1.25mm

Tapered Implants 1.25mm

External Connection Std. Implants 0.75mm3.75mm & 4mm diameter

External Connection Wide Implants 0.50mm5mm & 6mm diameter

Note: A Countersink Drill is not needed.

• The implant collar will be above the bone crest.• The height of the implant platform above the bone crest varies with the implant type being placed–see diagram below.

Implant Collar Height

Certain® Internal Connection External Connection


Placement Comparison Diagram

1mm cover screw H

Bone Crest

Supracrestal

Bone Crest Bone Crest1mm cover screw H

1.25mm collar H

H = Height (mm)


11

Pick-Up And Delivery Of ImplantCare must be taken when inserting the Implant PlacementDriver Tip into the implant. A very low RPM must be used asyou approach the internal connection of the implant with thedriver tip to properly align the internal hex of the implant withthe external hex of the driver. Press down firmly to engage theimplant securely.

NOTE: The Certain MicroMiniplant™ 3.25mm(D) Implantrequires the use of a dedicated MicroMiniplant Driver Tip(IMPDTS or IMPDTL) that is marked with a purple band on theshank. The internal connection configuration of theMicroMiniplant is smaller than the standard Certain InternalConnection (4, 5 and 6mm(D) implants). The item numbers canbe identified on the side of the driver tip.

Pick-Up And Delivery Of Cover Screw Or Healing AbutmentThe 0.048 inch tip of the Certain Implant Placement Drivercan be used to pick up and place the cover screw or thehealing abutment.

NOTE: When using the Internal Connection Implant Driver(IIPDTS or IIPDTL), reduce the torque setting on the drillingunit to 10Ncm.

The cover screw replica portion of the driver allows for visualverification of the cover screw position, making subcrestaland crestal placement of the implant predictable.

NOTE: Periodic O-Ring replacement is required for the CertainDriver Tips.

Implant pick-up

Implant and driver hex design

Hex

Cover screw pick-up

Subcrestal PlacementCrestal Placement

Mountless Delivery Guidelines ForCertain® Internal Connection Implants


12

Important Information Concerning Countersink DrillsCD500 And CD600:A second depth mark has been added to the 5mm and 6mmdiameter Countersink Drills (CD500 & CD600). The bottomline (closest to the apex) is positioned where the original

single line has traditionally been. The top line (closest to theshank) has been added to accommodate the Certain® InternalConnection Implant.

Crestof Bone

BIOMET 3i ExternalConnection Implant

Subcrestal Implant Placement

Countersink Drill Marking System

BIOMET 3i CertainInternal Connection Implant

BIOMET 3i ExternalConnection Implant

Crestal Implant Placement

BIOMET 3i CertainInternal Connection Implant

CrestalPlacement

SubcrestalPlacement

BIOMET 3i Expanded Platform (XP)Certain Internal Connection Implant

CD500 orCD600

CD500 orCD600

Important Information Concerning Countersink DrillsICD100, CD4500 And CD5600:

ICD100

CD4500 CD5600


13

Parallel Walled ImplantSurgical Tray

The Parallel Walled Implant Surgical Tray(PSKT) should be used for placement ofBIOMET 3i Paralled Walled Implants.


14

The protocols detailed in this Surgical Manual have beendeveloped to include more specific information about drillselection when working in various bone densities. However,the clinician is responsible for assessing the bone density ofthe anatomy when determining the appropriate protocol.

A Standard or a Stepped Surgical Protocol can beimplemented to prepare the osteotomy for implantplacement. The Standard Protocol prepares an osteotomythat is relatively straight from the apical to coronal aspect.The Stepped Protocol prepares an osteotomy that isundersized at the apex to accommodate the apical taper ofthe implant.

The various bone densities can be typically characterized bythe following:

Dense (Type I) – A thick cortical layer and a very high densitytrabecular core

Medium (Type II & III) – A cortical layer of moderatethickness with a reasonably dense trabecular core

Soft (Type IV) – A thin cortical layer and a low densitytrabecular core

Bone Density

Dense (Type I)

Medium (Type II)

Medium (Type III)

Soft (Type IV)


15

Quick Reference Surgical Protocol

See page 20 for detailed instructions.

2mmTwist Drill

Pilot DrillPD100

Skip StepFor Soft Bone

2.75mm Twist Drill(Medium Bone)3mm Twist Drill(Dense Bone)

C’sink DrillICD100

ACT PointedStarter DrillACTPSD orRound Drill

RD100

Certain PREVAIL® 3/4/3mm Diameter Implant

3/4mmC’sinkDepth

IndicatorICDI100

3.25mm(D) X 4.1mm(C) X3.4mm(P) X 11.5mm(L) Implant

Cover ScrewIMCSF34

MicroMiniplantDense Bone Tap

(Optional)MTAP1


ACT® PointedStarter DrillACTPSD orRound Drill

RD100

2mmTwist Drill

Pilot DrillPD100

(Final Drill ForSoft Bone)

2.75mmTwist Drill

(Medium Bone)3mm Twist Drill(Dense Bone)

Certain® Internal Connection MicroMiniplant™ 3.25mm And External Connection MicroMiniplant 3.25mm Diameter Implants

Cover ScrewIMMCS1

3.25mm(D) x 11.5mm(L)Implant


(Optional)MTAP1

Cover ScrewMMCS1

(D) = Diameter (mm)(C) = Collar (mm)(P) = Platform (mm)(L) = Length (mm)

• The recommended drill speed for drills 3.85mm diameter or less is 1200–1500rpm.• The recommended drill speed for drills 4.25mm diameter or greater is 900rpm.• The recommended implant placement speed is 15–20rpm.• The implant placement torque may exceed 50Ncm.• Final Twist Drill selection is based on clinician evaluation of bone quality.• Tapping is recommended for implant placement in dense bone (Type I).• Hand ratcheting may be necessary to fully seat the implant in the osteotomy.

NOTE:

16

XP External Connection 3/4mm Diameter Implant

Cover ScrewCS375

3.25mm(D) x 4.1mm(C)x 11.5mm(L) Implant


C’sink DrillCD100

External Connection 3.75mm Diameter Implant

Cover ScrewCS375

3.75mm(D) x 4.1mm(C)x 11.5mm(L) Implant



(Optional)MTAP1

2mmTwist Drill Pilot Drill

PD100




RD100

3/4mmC’sinkDepth

IndicatorICDI100

MicroMiniplant™

Dense Bone Tap(Optional)

MTAP1

C’sink DrillCD100


PD100




RD100

Quick Reference Surgical Protocol(Continued)



NOTE:

17

Certain® PREVAIL® 4/3mm And Certain Internal Connection 4mm Diameter Implants


2mmTwist Drill

Pilot DrillPD100

2.75mm Twist Drill(Soft Bone)

3mm Twist Drill(Medium Bone)

3.25mm Twist Drill(Dense Bone)



RD100

Cover ScrewIMCSF34

4mm(D) x 4.1mm(C) x3.4mm(P) x 11.5mm(L) Implant

4mm DenseBone Tap(Optional)TAP413

4mm(D) X 11.5mm(L)Implant

Cover ScrewICSF375



External Connection 4mm Diameter Implant

Cover ScrewCS375

4mm(D) x 11.5mm(L)Implant


2mmTwist Drill

Pilot DrillPD100





RD100

C’sink DrillCD100


18

Cover ScrewICSF41

5mm(D) x 4.1mm(P)x 11.5mm(L) Implant


Certain PREVAIL 5/4mm, Certain Internal Connection 5mm And External Connection 5mm Diameter Implants

Cover ScrewICS500

Cover ScrewCS600



Certain InternalConnection

ExternalConnection

5mm DenseBone Tap(Optional)TAP53S

2mmTwist Drill

Pilot DrillPD100

5mm C’sink CD500(Final Drill for

Soft Bone)


RD100

3.85mmTwist Drill

(Medium Bone)4.25mm

Twist Drill(Dense Bone)

3.25mmTwist Drill

Certain® PREVAIL® 4/5/4mm, XP Certain Internal Connection 4/5mm And XP External Connection 4/5mm Diameter Implants


2mmTwist Drill

Pilot DrillPD100

C’sinkCD4500





RD100

4/5mmC’sink Depth

IndicatorCDI4500

Cover ScrewICSF41




4mm(D) x 5mm(P) x11.5mm(L) Implant



NOTE:

Cover ScrewICS500

Cover ScrewCS600

19


5mm(D) x 5.8mm(C) x 5mm(P)x 11.5(L)mm Implant

5mm(D) x 6mm(P)x 11.5(L)mm Implant

Certain® PREVAIL® 5/6/5mm, XP Certain Internal Connection 5/6mm And XP External Connection 5/6mm Diameter Implants


Cover ScrewICSF50

Cover ScrewICS600

Cover ScrewCS600

Certain Internal Connection 6mm And External Connection 6mm Diameter Implants


Cover ScrewICS600

Cover ScrewCS600


Certain InternalConnection

ExternalConnection


RD100


PD100

5mmC’sink CD500


3.85mmTwist Drill

(Medium Bone)4.25mm


5/6mmC’sink

CD5600

5/6mmC’sink Depth

IndicatorCDI56003.25mm

Twist Drill


2mmTwist Drill

Pilot DrillPD100

5mm C’sink DrillCD500

6mm C’sinkCD600 (Final Drill

For Soft Bone)

4.25mmTwist Drill

3.25mmTwist Drill

4.85mmTwist Drill

(Medium Bone)5.25mm




RD100


20

For a quick reference guide to implant placement, refer to page15 for Certain Internal Connection MicroMiniplant 3.25mm andExternal Connection MicroMiniplant 3.25mm Diameter Implants.

1. Once the implant site has been determined, markthe site with the ACT® Pointed Starter Drill or RoundDrill and penetrate the cortical bone. The recommendeddrill speed is 1200–1500rpm.

• Instruments needed:ACT Pointed Starter Drill (ACTPSD)Round Drill (RD100 or DR100)

2. Proceed with the Initial Twist Drill toapproximately 7mm, then verify the direction with thethin portion of the Direction Indicator.

Continue to penetrate the bone to the desired depth.The recommended drill speed is 1200–1500rpm.

• Instruments needed:2mm Twist DrillDirection Indicator (DI100 or DI2310)

3. Verify the direction and position of thepreparation by inserting the thin portion of the DirectionIndicator into the osteotomy. Thread dental flossthrough the hole to prevent accidental swallowing.

At this step, a Gelb Radiographic Depth Gauge may alsobe used.

• Instruments needed:Direction Indicator (DI100 or DI2310)Gelb Radiographic Depth Gauge (XDGXX)

Subcrestal Surgical ProtocolCertain® Internal Connection MicroMiniplant™ 3.25mm And

External Connection MicroMiniplant 3.25mm Diameter Implants

1.53.4

2.4 2.4

.7

3.42.5

1.5


21

4. Use the Pilot Drill to shape the coronal aspect ofthe implant site. Drill to the depth mark.The recommended drill speed is 1200–1500rpm.

For soft bone (Type IV), this is the final drill. Proceed tostep 1 on page 42 for implant placement.

• Instruments needed:Pilot Drill (PD100 or DP100)

5. Once proper alignment is verified using theDirection Indicator, proceed with the 2.75mm Twist Drillto the desired depth for implant placement in mediumbone (Type II and III). Proceed with the 3mm Twist Drillto the desired depth for implant placement in densebone (Type I). The recommended drill speed is1200–1500rpm.

• Instruments needed:2.75mm Twist Drill for medium bone (Type II and III)3mm Twist Drill for dense bone (Type I)

Optional Tapping Step For Dense Bone (Type I)If placing a 3.25mm diameter implant in dense bone(Type I), using a Bone Tap is recommended.

• Instruments needed:Bone Tap (MTAP1 or MTAP2)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)

Proceed to step 1 on page 42 for implant placement.

For more information on various bone densities pleasesee page 14.

Subcrestal Surgical Protocol (Continued)Certain® Internal Connection MicroMiniplant™ 3.25mm And

External Connection MicroMiniplant 3.25mm Diameter Implants

Optional Step


22

For a quick reference guide to implant placement, refer topage 15 for the Certain PREVAIL 3/4/3mm Diameter Implant.

1. Once the implant site has been determined, mark thesite with the ACT® Pointed Starter Drill or Round Drilland penetrate the cortical bone. The recommended drillspeed is 1200–1500rpm.


2. Proceed with the initial Twist Drill to approximately7mm, then verify the direction with the thin portion ofthe Direction Indicator.



3. Verify the direction and position of the preparationby inserting the thin portion of the Direction Indicatorinto the osteotomy. Thread dental floss through the holeto prevent accidental swallowing.



4. Use the Pilot Drill to shape the coronal aspect of theimplant site. Drill to the depth mark. The recommendeddrill speed is 1200–1500rpm.


For soft bone (Type IV), skip step 5 and proceed to step 6on page 23.

Subcrestal Surgical ProtocolCertain® PREVAIL® 3/4/3mm Diameter Implant 1.5

4.1

3.4

2.4

!

!3.25


23

Subcrestal Surgical Protocol (Continued)Certain® PREVAIL® 3/4/3mm Diameter Implant

5. Once proper alignment is verified using the DirectionIndicator, proceed with the 2.75mm Twist Drill to thedesired depth for implant placement in medium bone(Type II and III). Proceed with the 3mm Twist Drill to thedesired depth for implant placement in dense bone (Type I).The recommended drill speed is 1200–1500rpm.


6. Use the Certain Countersink Drill to shape thecoronal aspect of the osteotomy. Drill to the top of thedepth mark for subcrestal placement. The recommendeddrill speed is 1200–1500rpm.

• Instruments needed:Certain Countersink Drill (ICD100)

NOTE: Drilling to the bottom of the depth mark on theICD100 will prepare the osteotomy for crestal placement andnot subcrestal placement of implant. (Refer to page 12).

7. Verify the direction and position of the preparationby inserting the 3/4mm Countersink Depth Indicator intothe osteotomy.

• Instruments needed:Countersink Depth Indicator (ICDI100)


• Instruments needed:Bone Tap (MTAP1 or MTAP2)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)



Optional Step


24

For a quick reference guide to implant placement, refer to page16 for the XP External Connection 3/4mm Diameter Implant.



2. Proceed with the Initial Twist Drill to approximately7mm, then verify the direction with the thin portion ofthe Direction Indicator.









Subcrestal Surgical ProtocolXP External Connection 3/4mm

Diameter Implant

.7

4.12.7

.75

2.4

!

!3.25


25

5. Once proper alignment is verified using the DirectionIndicator, proceed with the 2.75mm Twist Drill to thedesired depth for implant placement in medium bone(Type II and III). Proceed with the 3mm Twist Drill to thedesired depth for implant placement in dense bone(Type I). The recommended drill speed is 1200–1500rpm.


6. Using the Countersink Drill, prepare the bone toaccept the 4.5mm flared cover screw of the implant forsubcrestal placement. Drill to the center of the depthmark for subcrestal placement. The recommended drillspeed is 1200–1500rpm.

• Instruments needed:Countersink Drill (CD100)

7. Verify the direction and position of the preparation byinserting the Countersink Depth Indicator into theosteotomy.

• Instruments needed:Countersink Depth Indicator (ICD100)


• Instruments needed:Bone Tap - 3.25mm (MTAP1 or MTAP2)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)



Subcrestal Surgical Protocol (Continued)XP External Connection 3/4mm

Diameter Implant

Optional Step


26

For a quick reference guide to implant placement, refer to page16 for the External Connection 3.75mm Diameter Implant.












Subcrestal Surgical ProtocolExternal Connection 3.75mm

Diameter Implant

2.3

4.1

.75

2.7.7


27

5. Once proper alignment is verified using the DirectionIndicator, proceed with the 2.75mm Twist Drill to thedesired depth for implant placement in medium bone(Type II and III). Proceed with the 3mm Twist Drill to thedesired depth for implant placement in dense bone(Type I). The recommended drill speed is 1200–1500rpm.


6. Using the Countersink Drill, prepare the bone toaccept the 4.5mm flared cover screw of the 3.75mmdiameter implant for subcrestal placement. Drill to thecenter of the depth mark for subcrestal placement. Therecommended drill speed is 1200–1500rpm.

• Instruments needed:Countersink Drill (CD100)


• Instruments needed:Bone Tap - 3.75mm (TAP10, TAP13 or TAP20)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)



Subcrestal Surgical Protocol (Continued)External Connection 3.75mm

Diameter Implant

Optional Step


For a quick reference guide to implant placement, refer to page 17for Certain PREVAIL 4/3mm, Certain Internal Connection 4mmand External Connection 4mm Diameter Implants.

1. Once the implant site has been determined, markthe site with the ACT® Pointed Starter Drill or Round Drilland penetrate the cortical bone. The recommended drillspeed is 1200–1500rpm.


2. Proceed with the initial Twist Drill toapproximately 7mm, then verify the direction with thethin portion of the Direction Indicator.






4. Use the Pilot Drill to shape the coronal aspectof the implant site. Drill to the depth mark. Therecommended drill speed is 1200–1500rpm.


Subcrestal Surgical ProtocolCertain® PREVAIL® 4/3mm, Certain Internal Connection 4mm

And External Connection 4mm Diameter Implants1.0

2.6

4.14.1

2.6 2.6

4.1

.75

2.7.7

3.4

28

!

!4.0

.5


29

5. Once proper alignment is verified using theDirection Indicator, proceed with the 2.75mm Twist Drillto the desired depth for implant placement in soft bone(Type IV). Proceed with the 3mm Twist Drill to thedesired depth for implant placement in medium bone(Type II and III). Proceed with the 3.25mm Twist Drill forimplant placement in dense bone (Type I). Therecommended drill speed is 1200–1500rpm.

• Instruments needed:2.75mm Twist Drill for soft bone (Type IV)3mm Twist Drill for medium bone (Type II and III)3.25mm Twist Drill for dense bone (Type I)

6. Using the Countersink Drill, prepare the bone toaccept the 4.5mm flared cover screw of the 4mmdiameter implant and to accept the platform of theCertain PREVAIL 4/3mm Implant for subcrestal place-ment. The recommended drill speed is 1200–1500rpm.

• Instruments needed:Countersink Drill (ICD100) - Certain Internal

Connection (Drill to the top of the laser line forsubcrestal placement)

Countersink Drill (CD100) - ExternalConnection (Drill to the center of the laser line forsubcrestal placement)

Optional Tapping Step For Dense Bone (Type I)If placing a 4mm diameter implant in dense bone (Type I),using a bone tap is recommended.

• Instruments needed:Bone Tap (TAP410, TAP413 or TAP420)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)



Subcrestal Surgical Protocol (Continued)Certain® PREVAIL® 4/3mm, Certain Internal Connection 4mm

And External Connection 4mm Diameter Implants

Optional Step


30

For a quick reference guide to implant placement, refer to page 18 forCertain PREVAIL 4/5/4mm, XP Certain Internal Connection 4/5mmand XP External Connection 4/5mm Diameter Implants.









4. Use the Pilot Drill to shape the coronal aspectof the implant site. Drill to the depth mark.The recommended drill speed is 1200–1500rpm.


Subcrestal Surgical ProtocolCertain® PREVAIL® 4/5/4mm, XP Certain Internal Connection

4/5mm And XP External Connection 4/5mm Diameter Implants1.5 1.5

4.1

4.8

!

!4.0

2.6

5.02.7

2.6

!

!4.0

5.0

2.6

1.5

!

!4.0


31

5. Once proper alignment is verified using theDirection Indicator, proceed with the 2.75mm Twist Drill tothe desired depth for implant placement in soft bone (TypeIV). Proceed with the 3mm Twist Drill to the desired depthfor implant placement in medium bone (Type II and III).Proceed with the 3.25mm Twist Drill to the desired depthfor implant placement in dense bone (Type I). Therecommended drill speed is 1200–1500rpm.

• Instruments needed:2.75mm Twist Drill for soft bone (Type IV)3mm Twist Drill for medium bone (Type II and III)3.25mm Twist Drill for dense bone (Type I)

6. Using the Countersink Drill, prepare the bone toaccept the 4.5mm flared cover screw of the 4mmdiameter implant and to accept the platform of theCertain PREVAIL 4/3mm Implant for subcrestal place-ment. The recommended drill speed is 1200–1500rpm.

• Instruments needed:Countersink Drill (ICD100) - Certain Internal

Connection (Drill to the top of the laser line forsubcrestal placement)

Countersink Drill (CD100) - ExternalConnection (Drill to the center of the laser line forsubcrestal placement)

7. Use the flared cutting edge on the 4/5Countersink Drill to shape the coronal aspect of theosteotomy. Drill to the top of the depth mark forsubcrestal placement. The recommended drill speed is1200–1500rpm.

• Instruments needed:4/5 Countersink Drill (CD4500)

NOTE: Drilling to the bottom of the depth mark on theCD4500 will prepare the osteotomy for crestal placementand not subcrestal placement of implant.

8. Verify the direction and position of thepreparation by inserting the Countersink Depth Indicatorinto the osteotomy.

• Instruments needed:4/5 Countersink Depth Indicator (CDI4500)

Subcrestal Surgical Protocol (Continued)Certain® PREVAIL® 4/5/4mm, XP Certain Internal Connection

4/5mm And XP External Connection 4/5mm Diameter Implants


32


• Instruments needed:Bone Tap (TAP410, TAP413 or TAP420)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)





Optional Step


33

For a quick reference guide to implant placement, refer to page18 for Certain PREVAIL 5/4mm, Certain Internal Connection5mm and External Connection 5mm Diameter Implants.



2. Proceed with the initial Twist Drill toapproximately 7mm, then verify the direction with thethin portion of the Direction Indicator.






4. Use the Pilot Drill to shape the coronal aspect ofthe implant site. Drill to the depth mark. The recom-mended drill speed is 1200–1500rpm.


Subcrestal Surgical ProtocolCertain® PREVAIL® 5/4mm, Certain Internal Connection5mm And External Connection 5mm Diameter Implants

1.25

3.13.1

5.0

3.1

.5

5.02.7

.75.0

4.1

.5


34

5. Once proper alignment is verified using theDirection Indicator, proceed with the 3.25mm Twist Drillto the desired depth. The recommended drill speed is1200–1500rpm.

• Instruments needed:3.25mm Twist Drill

6. Use the 5mm Countersink/Pilot Drill to shapethe coronal aspect of the implant site. For subcrestalplacement of a Certain Internal Connection Implant, drill tothe center of the top depth mark. For subcrestalplacement of an External Connection Implant, drill to thecenter of the bottom depth mark. The recommended drillspeed is 900-1200rpm.

• Instruments needed:5mm Countersink/Pilot Drill (CD500)


7. Once the coronal aspect of the osteotomy hasbeen prepared, proceed with the 3.85mm Twist Drill tothe desired depth for implant placement in mediumbone (Type II and III). Proceed with the 4.25mm TwistDrill to the desired depth for implant placement in densebone (Type I). The recommended drill speed is900–1200rpm.

• Instruments needed:3.85mm Twist Drill for medium bone(Type II and III) (ACT3815)4.25mm Twist Drill for dense bone (Type I)


• Instruments needed:Bone Tap (TAP58S, TAP53S or TAP518S)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)



Subcrestal Surgical Protocol (Continued)Certain® PREVAIL® 5/4mm, Certain Internal Connection 5mm

And External Connection 5mm Diameter Implants

Optional Step


35

For a quick reference guide to implant placement, refer to page19 for Certain PREVAIL 5/6/5mm, XP Certain Internal Connection5/6mm and XP External Connection 5/6mm Diameter Implants.









4. Use the Pilot Drill to shape the coronal aspectof the implant site. Drill to the depth mark.The recommended drill speed is 1200–1500rpm.


1.5 1.55.8

!

!

5.0

3.1 3.1

5.0

6.02.7

!

!

5.0

Subcrestal Surgical ProtocolCertain® PREVAIL® 5/6/5mm, XP Certain Internal Connection 5/6mm

And XP External Connection 5/6mm Diameter Implants

3.1

6.0

1.5

!

!5.0


36



6. Advance the 5mm Countersink/Pilot Drill to widenthe coronal aspect of the osteotomy. The recommendeddrill speed is 900-1200rpm.

• Instrument needed:5mm Countersink/Pilot Drill (CD500)


7. Proceed with the 3.85mm Twist Drill to thedesired depth for implant placement in mediumbone(Type II and III). Proceed with the 4.25mm TwistDrill for implant placement in dense bone (Type I). Therecommended drill speed is 900–1200rpm.

• Instruments needed:3.85mm Twist Drill for medium bone (Type II and III)4.25mm Twist Drill for dense bone (Type I)

8. Use the flared cutting edge on the 5/6mmCountersink Drill to shape the coronal aspect of theosteotomy. Drill to the top of the depth mark forsubcrestal placement. The recommended drill speed is900-1200rpm.

• Instruments needed:5/6mm Countersink Drill (CD5600)

NOTE: Drilling to the bottom of the depth mark on theCD5600 will prepare the osteotomy for crestal placementand not subcrestal placement of implant. (Refer to page 12).




37

9. Verify the direction and position of the preparationby inserting the 5/6mm Countersink Depth Indicator intothe osteotomy.

• Instruments needed:5/6mm Countersink Depth Indicator (CDI5600)

Optional Tapping Step For Dense Bone (Type I)If placing a 5mm diameter implant in dense bone(Type I), using a bone tap is recommended

• Instruments neededBone Tap (TAP58S, TAP53S or TAP518S)Ratchet Wrench (WR150)Ratchet Extension (RE100, RE200)





Optional Step


38

For a quick reference guide to implant placement, refer topage 19 for Certain Internal Connection 6mm andExternal Connection 6mm Diameter Implants.

1. Once the implant site has been determined, markthe site with the ACT® Pointed Starter Drill or Round Drill andpenetrate the cortical bone. The recommended drill speed is1200–1500rpm.


2. Proceed with the Initial Twist Drill toapproximately 7mm, then verify the direction with thethin portion of the Direction Indicator.


• Instruments needed:2mm Direction Indicator (DI100 or DI2310)




Subcrestal Surgical ProtocolCertain® Internal Connection 6mm And

External Connection 6mm Diameter Implants1.25

4.1

6.0

4.1

.5

6.02.7

.7


39

4. Use the Pilot Drill to shape the coronal aspect ofthe implant site. Drill to the depth mark. The recom-mended drill speed is 1200–1500rpm.




6. Advance the 5mm Countersink/Pilot Drill towiden the coronal aspect of the osteotomy, allowingthe 4.25mm Twist Drill to enter the osteotomy. Therecommended drill speed is 900-1200rpm.

• Instrument needed:5mm Countersink/Pilot Drill (CD500)

7. Once the coronal aspect of the osteotomy hasbeen prepared, proceed with the 4.25mm Twist Drill tothe desired depth. The recommended drill speed is900-1200rpm.


Subcrestal Surgical Protocol (Continued)Certain® Internal Connection 6mm And

External Connection 6mm Diameter Implants


40

8. Use the 6mm Countersink/Pilot Drill to shape thecoronal aspect of the implant site. For subcrestalplacement of a Certain Internal Connection Implant, drillto the center of the top depth mark. For subcrestalplacement of an External Connection Implant, drill to thecenter of the bottom depth mark. The recommended drillspeed is 900-1200rpm.

• Instruments needed:6mm Countersink/Pilot Drill (CD600)


9. Once the coronal aspect of the osteotomy hasbeen prepared, proceed with the 4.85mm Twist Drillto the desired depth for implant placement in mediumbone (Type II and Type III). Proceed with the 5.25mmTwist Drill to the desired depth for implant placementin dense bone (Type I). The recommended drill speedis 900-1200rpm.

• Instruments needed:4.85mm Twist Drill for medium bone (Type II and III)5.25mm Twist Drill for dense bone (Type I)


Optional Tapping Step For Dense Bone (Type I)If placing a 6mm diameter implant in dense bone(Type I), using a bone tap is recommended.

• Instruments needed:Bone Tap (TAP685, TAP635 or TAP 6185)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)



Subcrestal Surgical Protocol (Continued)Certain® Internal Connection 6mm And

External Connection 6mm Diameter Implants

Optional Step


The following is an optional approach to preparing the implant site.This will result in a stepped osteotomy that is undersized at theapex to accommodate the apical taper of the implant. A steppedosteotomy can be achieved by employing the final Twist Drill 3mmshort of the desired implant length. The following examples are formedium bone only.

41

Certain® 3.25mm Diameter Parallel Walled Implant In Medium Bone1. Follow steps 1-4 on pages 20-21.

2. Proceed with the 2.75mm Twist Drill to 3mm short of thedesired depth.


Certain 4mm Diameter Parallel Walled Implant In Medium Bone1. Follow steps 1-4 on page 28.

2. Proceed with the 3mm Twist Drill to 3mm short of thedesired depth.

3. Using the Countersink Drill, prepare the bone to acceptthe 4.5mm flared cover screw of the 4mm diameterimplant for subcrestal placement

• Instruments Needed:Certain Internal Connection: Countersink Drill(ICD100) - (drill to the top of the laser line forsubcrestal placement)External connection: Countersink Drill (CD100) –(drill to the center of the laser line for subcrestalplacement)


Certain 5mm Diameter Parallel Walled Implant In Medium Bone1. Follow steps 1-6 on pages 33-34.



Certain 6mm Diameter Parallel Walled Implant In Medium Bone1. Follow steps 1-8 on pages 38-40.



Subcrestal Stepped Surgical Protocol


42

No-Touch™ Delivery System1. Remove contents from the implant box.

2. A nonsterile assistant should peel back the traylid and drop the No-Touch Implant Tray onto thesterile drape.

3. Place the No-Touch Implant Tray into theappropriate location on the surgical tray.

4. Peel back the tray lid to expose the implant andcover screw.

Subcrestal Implant Placement ProtocolCertain® Internal Connection And External Connection Implants


43

5. Pick up the implant from the surgical tray using theCertain Implant Placement Driver Tip (IIPDTS or IIPDTL).NOTE: The Certain PREVAIL® 3/4/3mm, 4/3mm and CertainMicroMiniplant™ 3.25mm Implants require the use of adedicated MicroMiniplant Driver Tip (IMPDTS or IMPDTL)that is marked with a purple band on the shank. The inter-nal connection configuration of the MicroMiniplant issmaller than the standard Certain Internal Connection 4, 5and 6mm Diameter Implants. The item numbers can beidentified on the side of the driver tip.

orPick up the implant from the surgical tray using

the Handpiece Connector.Carry the implant to the mouth facing upward to

prevent accidental dislodging.

• Instruments needed:Implant Placement Driver Tip (IIPDTS or IIPDTL)or Handpiece Connector

6. Place the implant in the prepared site atapproximately 15–20rpm. It is not uncommon for thehandpiece to stall before the implant is completelyseated. In dense bone (Type I), it is recommended totap the site with a Dense Bone Tap prior to implantplacement.

7. To remove the Certain Ratchet Extension fromthe implant, lift straight up and out.

To remove the implant mount, place the Open-End Wrench onto the mount. Loosen the screw at thetop of the mount with a Large Hex Driver or the LargeHex Driver Tip inserted into the Right-Angle Driver androtate counter-clockwise. After the screw is completelyloosened, rotate the Open-End Wrench counter-clockwise slightly, remove the Mount Driver tip andOpen-End Wrench at the same time.

• Instruments needed:Open-End Wrench (CW100), Large Hex Driver Tip(RASH3) and Right-Angle Driver (CATDB withCADD1) or a Large Hex Driver (PHD02N)

Subcrestal Implant Placement Protocol (Continued)Certain® Internal Connection And External Connection Implants


44

Subcrestal Implant Placement Protocol (Continued)Certain® Internal Connection And External Connection Implants

8. Pick up the Cover Screw from the No-Touch™Implant Tray with the Implant Driver or Large HexDriver and place onto the implant.

NOTE: When using the Certain Implant Placement Driver,reduce the torque setting on the drilling unit to 10Ncm.

• Instruments needed:Implant Placement Driver Tip (IIPDTS or IIPDTL)Large Hex Driver (PHD02N)

or

Pick up the Cover Screw from the No-TouchImplant Tray with the Small Hex Driver (PHD00N) andplace onto the implant.

NOTE: At this step, a temporary healing abutment may beplaced for single-stage surgery instead of a cover screw.

9. Close the tissue and suture.


45

Due to the geometrical differences that exist between atapered and a parallel walled implant, there are severalimportant technique adjustments that are required.

In all tapered implant placement procedures, the surgeonshould determine the appropriate vertical position of theimplant (supracrestal, crestal or subcrestal) at the timeof osteotomy preparation. The surgeon should preparethe tapered osteotomy so that when the implant is fullyseated, the implant seating surface is at the desiredposition. The Tapered Implant Depth/Direction Indicator(NTDI) was designed to simulate the tapered implantposition prior to placement. After preparation of theosteotomy with the final shaping drill, suction out theosteotomy to remove debris. Select the correspondingNTDI and place the tapered end into the osteotomy. Checkthe platform position (crestal or subcrestal) of the NTDI inrelation to the adjacent bone. This position locates wherethe platform of the tapered implant will be positioned whenproperly placed. If during placement with the power drill,the tapered implant platform is higher in relation to thebone than was demonstrated with the NTDI platform, theclinician should consider using a hand ratchet to completethe implant placement so that the tapered portion of theimplant body conforms correctly with the tapered portionof the osteotomy (Figure 1. Proper Subcrestal Placement).

Over Preparing the osteotomy depth and then placing theimplant at a crestal level may result in a conical spacearound the apical and coronal aspects of the taperedimplant with minimal thread engagement (Figure 2. OverPrepared Subcrestal Placement). This placement positionmay result in decreased implant to osteotomy contact, withcontact occurring only along the parallel coronal portion ofthe implant, resulting in decreased stability of the implant.

Under Preparing the osteotomy depth and then placing theimplant more apical relative to the prepared depth mayresult in the implant spinning and losing primary stability(Figure 3. Under Prepared Subrestal Placement).

Figure 2Over Prepared Subcrestal Placement Of 11.5mm Implant

Figure 1Proper Subcrestal Placement Of 11.5mm Implant

15

13

11.5

10

8.5

7

15

13

11.5

10

8.5

7

Proper Subcrestal PlacementOf Tapered Implants

15

13

11.5

10

8.5

7

Figure 3Under Prepared Subcrestal Placement Of 11.5mm Implant


46

The Quad Shaping Drills (QSDs) are used to prepare theosteotomy for placement of BIOMET 3i Tapered Implants.

The BIOMET 3i Depth Measurement System includes drilldepth marks on the ACT® Twist Drill that correspond to theplacement of the implant via a well-established procedure.BIOMET 3i’s Protocol follows the principles of protecting theimplant from premature loading by placing the implantsubcrestally.

The Quad Shaping Drills have been designed with geometricaldepth landmarks to assess proper depth rather than laseretched markings. The clinician should become familiar withthese depth landmarks to prevent over or under preparationof the osteotomy site.

Quad Shaping Drill Speed:QSDs should operate between 1200–1500rpm.

QSDs cut efficiently; reducing the downward force will allowthe drill to cut without detectable chatter.

Quad Shaping Drill Technique:• For either crestal or subcrestal implant placement, drill to

the top of either the crestal or subcrestal depth landmarkson the QSD (full depth - see illustration to the right).

• Do not pump the shaping drill as you might pump a twistdrill when creating the osteotomy. The shaping drill shouldbe advanced once to full depth, then be removed withoutany pumping action.

• Once the shaping drill has reached the desired depth, pull itout of the site without running the drill. If the drill does notpull out easily, tap the foot pedal while pulling the drill out.In addition to preserving the integrity of the osteotomy site,this technique maximizes autogenous bone recovery fromthe shaping drill flutes.

• When placing a tapered implant in soft bone (Type IV),the surgeon should consider undersizing the osteotomyby one shaping drill size (i.e. if placing a tapered 5mmdiameter X 10mm length implant in soft bone (Type IV),stop at the 4mm diameter X 10mm length shaping drilland directly place the implant).

• It is recommended that the clinician should tap theosteotomy when placing a tapered implant in dense bone(Type I).

NOTE: During preparation of the osteotomy, the shaping drillshould advance into the osteotomy using light pressure. Theneed to push heavily on the shaping drill may indicate theneed to replace the shaping drill, the need to tap or that theprevious drill depth was inadequate.

Quad Shaping Drill (QSD)For BIOMET 3i Tapered Implants

Depth landmarks on the QSD versus corresponding depth landmarkson the NTDI and depth marks on the ACT Drill for an 11.5mm lengthtapered implant.

*{

QSD NTDI

Supracrestal

CrestalSubcrestal

ParallelWalledCuttingFlutes

TaperedCuttingFlutes

Apical EndCutting

*Gingival Depth Marks - These depth marks are not used in the surgical procedurecovered in this manual.

ACT


47

Tapered ImplantDepth/Direction Indicator (NTDI)

The Tapered Implant Depth/Direction Indicator is used to simulatethe implant platform position prior to placing the implant.

Step 1When using the NTDI and after preparation of the osteotomy withthe final shaping drill, suction out the osteotomy to verify theosteotomy is clear of bone debris (Figure 1).

Step 2Verify the NTDI platform position in reference to the crest of thebone. This also verifies the depth of the osteotomy that has beencreated. The NTDI platform should be at the level you desire theimplant platform to attain. If the NTDI platform is too high versusthe desired position, then re-drilling to the appropriate depth isrequired. If the NTDI platform is too deep versus the desiredposition, this indicates some degree of osteotomy over preparationhas taken place. To ensure proper engagement of the implant, itmust be seated to the depth demonstrated by the NTDI. A longerimplant can be considered. The clinician may consider verifying theposition of the NTDI with a radiograph (Figure 2).

Step 3When placing the implant, the implant platform should reach thesame position that the NTDI platform previously attained. If theimplant platform is positioned higher in relation to the crest of thebone than the platform of the NTDI previously demonstrated, or ifthe surgical motor stalls prior to full placement of the implant due toinsufficient torque, then hand ratcheting is recommended to achievethe proper final implant seating position (Figure 3).

These guidelines are designed to help ensure good bone-to-implantcontact and primary stability of the implant.

Figure 1

Figure 2

Figure 3


48

Tapered Implant Bone TapsAnd Bone Tap Kit (NTAPK)

Dense Bone TapsWhen placing a tapered implant in dense bone (Type I),the clinician should consider tapping the osteotomy prior toimplant placement (Figure 1).

Dense Bone Taps are available to fully thread the entire osteotomy.These Dense Bone Taps are both length and diameter specific tocorrespond to each tapered implant (Figure 2).

Note: Dense Bone Taps shown on this page have replaced theStandard Tapered Bone Taps.

Tapered Implant Tap Kit (NTAPK)For Use With Tapered Implants In Dense BoneWhen placing a tapered implant, the need to tap the osteotomymay arise, especially in dense bone. The Dense Bone Tap Kit hasa specific tap that matches each tapered implant, which thenfacilitates site specific preparation to aid in final implant placement.

8.5mmOsteotomy

13mmOsteotomy

11.5mmOsteotomy

Figure 1

Figure 2Tapered Implant Tap Kit (NTAPK)


49

Tapered Implant Surgical Tray(QNTSK)

Coordinating The Use Of The Surgical Tray With TheSurgical Manual Illustrations:The Surgical Tray (QNTSK) for tapered implants is numbered to indicate theappropriate steps of the implant placement protocol. The following illustratedimplant placement protocol uses the same numbering sequence.

Close-up view of the Surgical Tray illustrating numbering sequence.

NOTE: The current editions of the Tapered Implant Surgical Tray have replaced the Round Drill with a Pointed StarterDrill and eliminated the Pilot Drill from the surgical protocol.


Jaime Rodrigo Reyes Toro

50


Quick Reference Surgical Protocol

2mmTwist Drill

3.25mmDepth/Direction

IndicatorNTDI3211

Cover ScrewIMMCS1

Cover ScrewMMCS1

3.25mmQuad Shaping

DrillQSD3211


(Optional)MTAP1

Tapered Certain® Internal Connection MicroMiniplant™ 3.25mm And Tapered External Connection MicroMiniplant 3.25mm Diameter Implants

ACT®

PointedStarter Drill

ACTPSD

2mmTwist Drill

4mmQuad Shaping

DrillQSD411

Cover ScrewIMCSF34

Cover ScrewICS375

3.25mmQuad Shaping

DrillQSD3211

(Final drill forsoft bone)

4mmDense Bone Tap

(optional)NTAP411

Tapered Certain PREVAIL® 4/3mm, Tapered Certain Internal Connection 4mm And Tapered External Connection 4mm Diameter Implants

ACTPointed

Starter DrillACTPSD

4mmDepth/Direction

IndicatorNTDI411


• The recommended drill speed for all drills is 1200–1500rpm.• The Quad Shaping Drills must be used without pumping actions.• The recommended implant placement speed is 15–20rpm.• The implant placement torque may exceed 50Ncm.• Tapping is recommended for implant placement in dense bone (Type I).• Undersizing the osteotomy by one shaping drill diameter is recommended for implant placement in soft bone (Type IV).• Hand ratcheting may be necessary to fully seat the implant in the osteotomy.

NOTE:


3.25mm(D) x 11.5mm(L)Implant


Cover ScrewCS375





51

Tapered Certain PREVAIL 6/5mm, Tapered Certain Internal Connection 6mm And Tapered External Connection 6mm Diameter Implants

2mmTwist Drill

4mmQuad Shaping

DrillQSD411

5mmQuad Shaping

DrillQSD511


6mmQuad Shaping

DrillQSD611

6mmDepth/Direction

IndicatorNTDI611

Cover ScrewICS600

Cover ScrewCS600

ACTPointed

Starter DrillACTPSD

3.25mmQuad Shaping

DrillQSD3211

6mmDense Bone Tap

(optional)NTAP611

2mmTwist Drill

4mmQuad Shaping

DrillQSD411


5mmQuad Shaping

DrillQSD511

5mmDepth/Direction

IndicatorNTDI511

Cover ScrewICS500

Cover ScrewCS500

3.25mmQuad Shaping

DrillQSD3211

5mmDense Bone Tap

(optional)NTAP511

Tapered Certain® PREVAIL® 5/4mm, Tapered Certain Internal Connection 5mm And Tapered External Connection 5mm Diameter Implants

ACT®

PointedStarter Drill

ACTPSD

Quick Reference Surgical Protocol (Continued)


• The recommended drill speed for all drills is 1200–1500rpm.• The Quad Shaping Drills must be used without pumping actions.• The recommended implant placement speed is 15–20rpm.• The implant placement torque may exceed 50Ncm.• Tapping is recommended for implant placement in dense bone (Type I).• Undersizing the osteotomy by one shaping drill diameter is recommended for implant placement in soft bone (Type IV).• Hand ratcheting may be necessary to fully seat the implant in the osteotomy.

NOTE:


5mm(D) x 5mm(C) x4.1mm(P) x 11.5mm(L) Implant


Cover ScrewICSF41

Cover ScrewICSF50


6mm(D) x 6mm(C) x5.0mm(P) x 11.5mm(L) Implant


52

Subcrestal Surgical ProtocolTapered Certain® Internal Connection MicroMiniplant™ 3.25mm And

Tapered External Connection MicroMiniplant 3.25mm Diameter Implants



2. Proceed with the Initial Twist Drill toapproximately 7mm, then verify the direction with thethin portion of the Direction Indicator. Thread flossthrough the hole to prevent accidental swallowing.

Continue to penetrate the bone to the desired depth.Set the drill speed at approximately 1200–1500rpm.





Final Shaping Drill Step For Tapered 3.25mm Implant In AllBone Densities4a. Proceed with the 3.25mm Quad Shaping Drill

(QSD32XX) that is the same length as the implant to beplaced. The recommended drill speed is 1200–1500rpm.

For a quick reference guide to implant placement, refer to page 50 forTapered Certain Internal Connection MicroMiniplant 3.25mm and TaperedExternal Connection MicroMiniplant 3.25mm Diameter Implants.

3.4

1.25

1.9

3.4

1.25

2.5.7

1.9








53

Preparation For Placement Of Tapered 3.25mm Implant InAll Bone Densities4b. Using suction, remove drilling debris from the

osteotomy before proceeding with the Depth/DirectionIndicator (NTDI).

IMPORTANT NOTE: When placing a 4mm diameterimplant subcrestally, you must use an ICD100 CountersinkDrill to prepare the ridge before placing the implant. TheICD100 is not required for crestal and supracrestalplacement of a 4mm diameter implant.

4c. Insert the tapered end of the 3.25mm (purple)NTDI that corresponds to the length of the implant to beplaced. This will simulate the position of the implantplatform in relation to the crest of the bone. If theposition of the NTDI does not indicate proper osteotomydepth, adjust the depth of the osteotomy with thecorresponding 3.25mm Quad Shaping Drill or consider alonger length implant if the site has been over prepared.Re-evaluate with a proper length NTDI.

Optional Tapping Step For Dense Bone (Type I)If placing a 3.25mm implant in dense bone (Type I),tapping with a Dense Bone Tap is recommended.

• Instruments needed:Dense Bone Tap (NTAP32XX)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)



Optional Step

Subcrestal Surgical Protocol (Continued)Tapered Certain® Internal Connection MicroMiniplant™ 3.25mm And

Tapered External Connection MicroMiniplant 3.25mm Diameter Implants


54

Subcrestal Surgical ProtocolTapered Certain® PREVAIL® 4/3mm, Tapered Certain Internal Connection

4mm And Tapered External Connection 4mm Diameter Implants









Final Shaping Drill Step For Tapered PREVAIL 4/3mm AndTapered 4mm Implants In Soft Bone (Type IV)4a. Proceed with the 3.25mm Quad Shaping Drill

(QSD32XX) that is the same length as the implant to beplaced. The recommended drill speed is 1200–1500rpm.

For a quick reference guide to implant placement, refer to page 50 forTapered Certain PREVAIL 4/3mm, Tapered Certain Internal Connection4mm and Tapered External Connection 4mm Diameter Implants.

3.4

4.1

2.4

1.25

4.1

1.25

2.4

1.25

2.4

2.7.7

4.1


55

Preparation For Placement Of Tapered PREVAIL 4/3mm AndTapered 4mm Implants In Soft Bone (Type IV)4b. Using suction, remove drilling debris from the

osteotomy before proceeding with the Depth/DirectionIndicator (NTDI).

IMPORTANT NOTE: When placing a 4mm diameterimplant subcrestally, you must use an ICD100 CountersinkDrill to prepare the ridge before placing the implant. TheICD100 is not required for crestal and supracrestalplacement of a 4mm diameter implant.

4c. Insert the tapered end of the 3.25mm (purple)NTDI that corresponds to the length of the implant to beplaced. This will simulate the position of the implantplatform in relation to the crest of the bone. If theposition of the NTDI does not indicate proper osteotomydepth, adjust the depth of the osteotomy with thecorresponding 3.25mm Quad Shaping Drill or consider alonger length implant if the site has been over prepared.Re-evaluate with a proper length NTDI.


Final Shaping Drill Step For Tapered PREVAIL 4/3mm AndTapered 4mm Implants In Medium (Type II And Type III) ToDense Bone (Type I)5a. Resume preparing the osteotomy with the 4mm

Quad Shaping Drill (QSD4XX) that is the same length asthe implant to be placed. The recommended drill speedis 1200–1500rpm.

Subcrestal Surgical Protocol (Continued)Tapered Certain® PREVAIL® 4/3mm, Tapered Certain Internal Connection



56

Optional Step

Preparation For Placement Of Tapered PREVAIL 4/3mm AndTapered 4mm Implants In Medium (Type II And Type III) ToDense Bone (Type I)5b. Using suction, remove drilling debris from the

osteotomy before proceeding to the Depth/DirectionIndicator (NTDI).

5c. Insert the tapered end of the 4mm (blue) NTDIthat corresponds to the length of the implant to beplaced. This will simulate the position of the implantplatform in relation to the crest of the bone. If theposition of the NTDI does not indicate properosteotomy depth, adjust the depth of the osteotomywith the corresponding 4mm Quad Shaping Drill orconsider a longer length implant if the site has beenover prepared. Re-evaluate with a proper length NTDI.

5d. Countersink the osteotomy with an ICD100 toaccommodate the cover screw for the 4mm implant.The recommended drill speed is 1200–1500rpm.

IMPORTANT NOTE: When placing a 4mm diameterimplant subcrestally, you must use an ICD100Countersink Drill to prepare the ridge before placing theimplant. The ICD100 is not required for crestal andsupracrestal placement of a 4mm diameter implant.

Optional Tapping Step For Dense Bone (Type I)If placing a 4mm implant in dense bone (Type I),tapping with a Dense Bone Tap is recommended.




Subcrestal Surgical Protocol (Continued)Tapered Certain® PREVAIL® 4/3mm, Tapered Certain Internal Connection



57











4a. Proceed with the 3.25mm Quad Shaping Drill(QSD32XX) that is the same length as the implant to beplaced. The recommended drill speed is 1200–1500rpm.


4.1

5.0

3.2

1.25

5.0

1.25

3.2

1.25

2.75.0

.7

3.2


Final Shaping Drill Step For Tapered PREVAIL 5/4mm AndTapered 5mm Implants In Soft Bone (Type IV)5a. Resume preparing the osteotomy with the 4mm




5c. Insert the tapered end of the 4mm (blue) NTDIthat corresponds to the length of the implant to beplaced. This will simulate the position of the implantplatform in relation to the crest of the bone. If theposition of the NTDI does not indicate proper osteotomydepth, adjust the depth of the osteotomy with thecorresponding 4mm Quad Shaping Drill or consider alonger length implant if the site has been over prepared.Re-evaluate with a proper length NTDI.






58


59

Preparation For Placement Of Tapered PREVAIL 5/4mm AndTapered 5mm Implants In Medium (Type II And Type III) ToDense Bone (Type I)6b. Using suction, remove drilling debris from the


6c. Insert the tapered end of the 5mm (yellow) NTDIthat corresponds to the length of the implant to beplaced. This will simulate the position of the implantplatform in relation to the crest of the bone. If theposition of the NTDI does not indicate proper osteotomydepth, adjust the depth of the osteotomy with thecorresponding 5mm Quad Shaping Drill or consider alonger length implant if the site has been over prepared.Re-evaluate with a proper length NTDI.





Optional Step




60











4. Proceed with the 3.25mm Quad Shaping Drill(QSD32XX) that is the same length as the implant to beplaced. The recommended drill speed is 1200–1500rpm.


6.0

5.0

1.25

3.9 3.9

6.0

1.25 1.25

2.76.0

.7

3.9


61

5. Resume preparing the osteotomy with the 4mmQuad Shaping Drill (QSD4XX) that is the same length asthe implant to be placed. The recommended drill speedis 1200–1500rpm.

Final Shaping Drill Step For Tapered PREVAIL 6/5mm AndTapered 6mm Implants In Soft Bone6a. Resume preparing the osteotomy with the 5mm




6c. Insert the tapered end of the 5mm (yellow) NTDIthat corresponds to the length of the implant to beplaced. This will simulate the position of the implantplatform in relation to the crest of the bone. If theposition of the NTDI does not indicate proper osteotomydepth, adjust the depth of the osteotomy with thecorresponding 5mm Quad Shaping Drill or consider alonger length implant if the site has been over prepared.Re-evaluate with a proper length NTDI.




62



Preparation For Placement Of Tapered PREVAIL 6/5mm AndTapered 6mm Implants In Medium (Type II And Type III) ToDense Bone (Type I)

7b. Using suction, remove drilling debris from theosteotomy before proceeding to the Depth/DirectionIndicator (NTDI).

7c. Insert the tapered end of the 6mm (green) NTDIthat corresponds to the length of the implant to beplaced. This will simulate the position of the implantplatform in relation to the crest of the bone. If theposition of the NTDI does not indicate proper osteotomydepth, adjust the depth of the osteotomy with thecorresponding 6mm Quad Shaping Drill or consider alonger length implant if the site has been over prepared.Re-evaluate with a proper length NTDI.





Optional Step




63

No-Touch™ Delivery System1. Remove contents from the implant box.

2. The nonsterile assistant should peel back thetray lid and drop the No-Touch Implant Tray onto thesterile drape.

3. Place the No-Touch Implant Tray into theappropriate location on the surgical tray.

4. Peel back the tray lid to expose the implant andcover screw.

Subcrestal Implant Placement ProtocolTapered Certain® Internal Connection And

Tapered External Connection Implants


64

Subcrestal Implant Placement Protocol (Continued)Tapered Certain® Internal Connection And


5. Pick up the implant from the surgical tray usingthe Certain Implant Placement Driver Tip.NOTE: The Tapered Certain PREVAIL® 3/4/3mm, Tapered4/3mm and Tapered Certain MicroMiniplant™ 3.25mmDiameter Implants require the use of a dedicatedMicroMiniplant Driver Tip (IMPDTS or IMPDTL) that ismarked with a purple band on the shank. The internalconnection configuration of the MicroMiniplant is smallerthan the standard Certain Internal Connection 4, 5 and6mm Diameter Implants. The item numbers can beidentified on the side of the driver tip.

orPick up the implant from the surgical tray using

the Handpiece Connector.Carry the implant to the mouth facing upward to

prevent accidental dislodging.

• Instruments needed:Implant Placement Driver Tip (IIPDTS or IIPDTL)or Handpiece Connector (MDR10)

6. Place the implant in the prepared site atapproximately 15–20rpm. It is not uncommon for thehandpiece to stall before the implant is completely seated.The implant position must match what was simulated withthe Depth/Direction Indicator (NTDI) or there is a risk of apoor fit between the implant and osteotomy. In densebone (Type I), it is recommended to tap the site with aDense Bone Tap prior to implant placement.

7. Final seating of the implant may require the useof the Ratchet Extension and the Ratchet Wrench.

• Instruments needed:Ratchet Wrench (WR150)Certain Ratchet Extension (IRE100 or IRE200) orMicroMiniplant Ratchet Extension (IMRE100 orIMRE200)External Connection Ratchet Extension(RE100 or RE200)

8. To remove the Certain Ratchet Extension from theimplant, lift straight up and out.

To remove the implant mount, place the Open-EndWrench onto the mount. Loosen the screw at the top ofthe mount with a Large Hex Driver or the Large HexDriver Tip inserted into the Right-Angle Driver and rotatecounter-clockwise. After the screw is loosened, rotate theOpen-End Wrench counter-clockwise slightly beforeremoving the mount. The mount may be carried from themouth with the Open-End Wrench.

• Instruments needed:Open-End Wrench (CW100), Large Hex Driver Tip(RASH3) and Right-Angle Driver (CATDB withCADD1) or a Large Hex Driver (PHD02N)


65

9. Pick up the Cover Screw from the No-Touch™Implant Tray with the Implant Driver or Large HexDriver and place onto the implant.

NOTE: When using the Certain Implant Placement Driver,reduce the torque setting on the drilling unit to 10Ncm.

• Instruments needed:Implant Placement Driver Tip (IIPDTS or IIPDTL)Large Hex Driver (PHD02N)

or

Pick up the Cover Screw from the No-TouchImplant Tray with the Small Hex Driver (PHD00N) andplace onto the implant.

NOTE: At this step, a temporary healing abutment may beplaced for single-stage surgery instead of a cover screw.

10. Close the tissue and suture.

Subcrestal Implant Placement Protocol (Continued)Tapered Certain® Internal Connection And



66

Tapered 4mm Diameter Implant1. After preparing the osteotomy with the

appropriate length 3.25mm QSD, finish with a 4mm x8.5mm QSD (QSD485). This will create an osteotomy ofproper dimension in the dense cortical bone to receivethe implant, but will slightly undersize the osteotomy inthe cancellous region to allow for some compression.The recommended drill speed is 1200–1500rpm.

2. Finish by countersinking the osteotomy with anICD100 to accommodate the cover screw for the 4mmimplant. The recommended drill speed is1200–1500rpm.

IMPORTANT NOTE: When placing a 4mm diameterimplant subcrestally, you must use a ICD100Countersink Drill to prepare the ridge before placing theimplant. The ICD100 is not required for crestal andsupracrestal placement of a 4mm diameter implant.

See step step 1 on page 63 for implant placement.


appropriate length 4mm QSD, finish with a 5mm x8.5mm Quad Shaping Drill (QSD585). This will createan osteotomy of proper dimension in the dense corticalbone to receive the implant, but will slightly undersizethe osteotomy in the cancellous region to allow forsome compression. The recommended drill speed is1200–1500rpm.



appropriate length 5mm QSD, finish with a 6mm x8.5mm Quad Shaping Drill (QSD685). This will createan osteotomy of proper dimension in the dense corticalbone to receive the implant, but will slightly undersizethe osteotomy in the cancellous region to allow forsome compression. The recommended drill speed is1200–1500rpm.


Subcrestal Stepped Surgical ProtocolTapered Certain® Internal Connection And Tapered External Connection

4mm, 5mm And 6mm ImplantsIt may be necessary to prepare the coronal aspect of theosteotomy as illustrated below. The following examplesare for medium bone only.


67

Bone Profiling

Emergence Profile (EP®) Healing AbutmentsBone Profiling Pins and corresponding EP Bone Profilers areavailable to contour the bone that is to receive the EP HealingAbutment. These tools are especially helpful in a single-stagesurgical protocol when the implant is placed subcrestally.

If the implant is placed subcrestally and use of an EPHealing Abutment is indicated, the coronal aspect of theosteotomy must be prepared to receive the flare of the EPHealing Abutment.

NOTE: Non-EP, straight healing abutments and impressioncopings are available if bone profiling is not preferred at eitherstage one or stage two surgery.

Certain® Internal Two-Piece Bone Profiling Pin (IBPGP)The Certain Internal Connection Implant requires a dedicatedBone Profiling Pin, which is used with the existing EP BoneProfilers. This new two-piece design allows the pin to engagethe internal connection of the implant. The hex engagementprevents the pin from tightening into the implant during pro-filing, making it easy to remove. Lubricating the top of thepin with an appropriate lubricant, such as tetracycline oint-ment, is recommended. Do not exceed 50rpm when usingBone Profilers.

Bone Profiling Technique

CertainInternal Connection

Two-PieceBone Profiler Pin

External ConnectionOne-Piece

Bone Profiler Pin

• EP Bone Profiler slides over theBone Profiler Pin.

• EP Bone Profiler creates aflare in the crest of bone.

• Flare of EP Abutment matchesthe flare of the correspondingEP Bone Profiler.

• EP Healing Abutment seatedproperly onto the implant insubcrestal placement.

EP Bone Profilers correspond to sizes of EP Healing Abutments


68

Surgeon1. For surgical implant placement of a BIOMET 3i Implant,

follow the normal protocol as described in the previoussections.

Surgical Indexing2. A surgical index may be made at stage one or stage two

to facilitate the fabrication of a provisional restoration.This can be accomplished by using a Pick-UpImpression Coping (or a Hexed Temporary Cylinder)with retention, a waxing screw and a medium-to-heavybody impression material.

Creating A Surgical Index3. Select the proper Pick-Up Impression Coping by

matching the diameter of the implant platform.

Activate the fingers using the QuickSeat® ActivatorTool. Place the Pick-Up Impression Coping or theTemporary Cylinder into the implant, line up the hexand press firmly until feeling the tactile click.

Place the Pick-Up Impression Coping or theTemporary Cylinder on the implant and engage the hex.

Thread the Pick-Up Impression Coping Screw or waxingscrew into the implant until finger tight. Tighten thescrew using the Large Hex Driver. If the ImpressionCoping touches the adjacent teeth, the ImpressionCoping may need to be modified with a bur or disc.

4. If a flapless surgery is performed or if the index is madeat stage two surgery, radiograph the interface to verifycomplete seating of the coping on the implant. Place thefilm perpendicular to the interface of the coping on theimplant.

Surgical Indexing

Seated Not Seated


69

5. Syringe a medium-to-heavy body impression materialaround the impression coping or temporary cylinderand over the occlusal surfaces of the adjacent teeth(approximately 1.5 teeth on either side). Allow theimpression material to set per the manufacturer’sinstructions. Once the material has set, remove theimpression coping screw or waxing screw using theLarge Hex Driver. Remove the surgical index from themouth. Send the index to the restorative clinician so thatit may be included in the package to the laboratory. Donot place a lab analog into the index.

6. Select a healing abutment by matching the implantplatform, preferred EP® Diameter and collar height.The collar height should be selected by measuring fromthe implant platform to the highest crest of the gingivaltissue and adding 1mm.

Surgical Indexing


70

There may be several advantages in utilizing a two-stageimplant system in a single-stage treatment protocol.Attaching a one-piece or two-piece healing abutmentimmediately following implant placement eliminates theneed for a second-stage surgery. Eliminating the secondsurgical procedure reduces trauma and decreases treatmenttime, while the two-stage implant design maintainsrestorative flexibility.

1. After the implant is fully seated in the osteotomy,remove the implant mount from the External ConnectionImplant.

2. Select the appropriate one-piece healingabutment or Encode® Healing Abutment depending uponthe implant seating surface, tissue depth and desiredEP® Dimension.

or

Select the appropriate one or two-piece healingabutment or Encode Healing Abutment depending uponthe implant seating surface, tissue depth and desired EPDimension.

Bone profiling of the osteotomy may benecessary to fully seat the healing abutment onto theimplant.

3. Tighten the one or two-piece healing abutmentscrew to 20Ncm and suture the soft tissue around thehealing abutment.

Single-Stage Treatment


NOTESIcon Key:

Certain Internal ConnectionImplant System:

External ConnectionImplant System:

Certain Internal Connectionand External ConnectionImplant System:

How To Use The Icon Key:

The icons represent the connection types of theBIOMET 3i Implant System and both internal andexternal connection types are represented in thismanual. In the fully illustrated protocols, each iconis present by each step. When a dark burgundy iconand a light burgundy icon are present together, thedark burgundy indicates which system is illustrated.When both icons are dark burgundy, then bothsystems are illustrated together.

Instructions For Use:

OSSEOTITE®, OSSEOTITE XP®, Certain®, PREVAIL®, Encode®, IOL®, Miniplant®,Microminiplant™, GingiHue®, Gold-Tite®, Provide®, STA®, ZiReal®, CAMStructSURE®, NanoTite™, PreFormance®, QuickBridge®

This document applies to dental implants, abutments, overdenture bars and associatedsurgical, restorative and dental laboratory components.

For detailed information on the specific procedure for the product you are using, please referto the individual product labels and/or the appropriate manual:

Product Catalog - CATALOG: Listing of all productsSurgical Manual - CATSM: Dental implant placement, surgical protocol and cover screw

insertionRestorative Manual - CATRM: Abutment placement, provisional and final

restoration protocolsAdditional Restorative Manuals:

CAM StructSURE Manual - ART868 DIEM® Guidelines - ART860Encode Restorative Manual - ART924 QuickBridge Manual - ART1016

Description: BIOMET 3i Dental Implants are manufactured from biocompatible titanium andtitanium alloy and abutments from titanium, titanium alloy, gold alloy and ceramic material.BIOMET 3i Dental Implants and Abutments include various surface treatments and coatings.Other restorative components are manufactured with titanium, titanium alloy, gold alloy,stainless steel and a variety of polymers.

For specific product description and net quantity refer to individual product labels.

Indications for Use: BIOMET 3i Dental Implants are intended for surgical placement in theupper or lower jaw to provide a means for prosthetic attachment in single tooth restorationsand in partially or fully edentulous spans with multiple single teeth utilizing delayed orimmediate loading, or as a terminal or intermediary abutment for fixed or removablebridgework and to retain overdentures.

BIOMET 3i OSSEOTITE and NanoTite Dental Implants are intended for immediate function onsingle tooth and/or multiple tooth applications when good primary stability is achieved, withappropriate occlusal loading, in order to restore chewing function.

Additional Indications: BIOMET 3i Dental Abutments and Overdenture Bars are intended foruse as an accessory to endosseous dental implants to support a prosthetic device in apartially or edentulous patient. These are intended for use to support single and multipletooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement-retained to the abutment.

PEEK Abutment Posts and Temporary Cylinders are intended for use as an accessory toendosseous dental implants to support a prosthetic device in a partially or fully edentulouspatient. These are intended for use to support single and multiple unit prostheses in themandible or maxilla for up to 180 days during endosseous and gingival healing and are fornon-occlusal loading of single and multiple unit provisional restorations. The prostheses canbe screw and/or cement-retained to the abutment. These Temporary Posts and Cylindersrequire a minimum interarch space of 6mm and a maximum angulation of 15°. These alsoallow for occlusal loading of single and multiple unit restorations of integrated implants forguided soft tissue healing.

The QuickBridge Provisional Components are intended to be mated with BIOMET 3i ConicalAbutments for use as an accessory to endosseous dental implants to support a prostheticdevice in a partially or fully edentulous patient. The QuickBridge Provisional Components areintended to support multiple unit prostheses in the mandible or maxilla for up to 180 daysduring endosseous and gingival healing.

Contraindication: Placement of dental implants may be precluded by patient conditions thatare contraindications for surgery. BIOMET 3i Dental Implants should not be placed in patientswhere the remaining jaw bone is too diminished to provide adequate implant stability.

Storage and Handling: Devices should be stored at room temperature. Refer to individualproduct labels and the Surgical Manual for special storage or handling conditions.

Warnings: Excessive bone loss or breakage of a dental implant or restorative device mayoccur when an implant or abutment is loaded beyond its functional capability. Physiologicaland anatomic conditions may negatively affect the performance of dental implants.

The following should be taken into consideration when placing dental implants:• Poor bone quality• Poor oral hygiene• Medical conditions such as blood disorders or uncontrolled hormonal conditions

It is recommended that small diameter implants not be restored with angled abutments inthe molar region.

Mishandling of small components inside the patient’s mouth carries a risk of aspirationand/or swallowing.

Forcing the implant into the osteotomy deeper than the depth established by the drills canresult in: stripping the driver hex interface inside the implant, stripping the driver, cold-welding of the mount-driver interface to the implant or stripping the walls of the osteotomythat may prevent an effective initial implant fixation.

Clinical data have demonstrated enhanced performance of OSSEOTITE Implants ascompared to other BIOMET 3i Dental Implants in patients with poor quality bone.

Precautions: For safe and effective use of BIOMET 3i Dental Implants, abutments and othersurgical and restorative dental accessories, these products or devices should only be used bytrained professionals. The surgical and restorative techniques required to properly utilizethese devices are highly specialized and complex procedures. Improper technique can lead toimplant failure, loss of supporting bone, restoration fracture, screw loosening and aspiration.

Sterility: All dental implants and some abutments are supplied sterile and are sterilized byan appropriate validated method. Refer to individual product labels for sterilizationinformation; all sterile products are labeled ‘STERILE.’ All products sold sterile are for singleuse before the expiration date printed on the product label. Do not use sterile products if thepackaging has been damaged or previously opened. Do not re-sterilize or autoclave exceptwhere instructions to do so are provided on the product label, in the Surgical Manual, in theRestorative Manual or in any additional marketing literature for that product. Productsprovided non-sterile must be cleaned and sterilized according to the directions found inART630 or the Surgical Manual prior to use.

Procedural Precautions, Surgery: For a detailed explanation of the procedural precautionsrefer to the Surgical Manual. During the planning phase, it is important to determine thevertical dimension, the actual space available between the alveolar crest and the opposingdentition, in order to confirm that the available space will accommodate the proposedabutment and the final crown restoration. This information varies with each patient andabutment; therefore it should be carefully evaluated before placing any dental implant.The final prosthesis should be designed prior to the placement of the dental implant.Utilize continuous irrigation with a cool, sterile irrigating solution to avoid excessive damageto the surrounding tissue and to prevent compromising osseointegration. This is mandatoryduring all procedures. Avoid excessive pressure during preparation of the bone site. As thedrilling speed varies based on the instrument and the surgical procedure, recommendationsfor speed can be found in the Surgical Manual. Only sharp instruments of the highest qualityshould be used for any surgical procedure involving bone. Minimizing trauma to the boneand surrounding tissue enhances the potential for successful osseointegration. In order toeliminate contaminants and other sources of infection, all non-sterile devices should becleaned and/or sterilized prior to use, per the instructions on the individual product labels.

Procedural Precautions, Restoration: The healing period varies depending on the quality ofthe bone at the implantation site, the tissue response to the implanted device and thesurgeon’s evaluation of the patient’s bone density at the time of the surgical procedure.Excessive force applied to the dental implant should be avoided during the healing period.Proper occlusion should be evaluated on the implant restoration to avoid excessive force.

Potential Adverse Events: Potential adverse events associated with the use of dentalimplants may include:

Caution: U.S. Federal Law restricts this device to sale by or on the order of a licenseddentist or physician.

• Failure to integrate• Loss of integration• Dehiscence requiring bone grafting• Perforation of the maxillary sinus,

inferior border, lingual plate, labial plate,inferior alveolar canal, gingiva

• Infection as reported by: abscess,fistula, suppuration, inflammation,radiolucency

• Persistent pain, numbness, paresthesia• Hyperplasia• Excessive bone loss requiring

intervention• Implant breakage or fracture• Systemic infection• Nerve injury

Surgical ManualCertain® Internal Connection And External ConnectionImplant Systems

Certain InternalConnection Implants

ExternalConnection Implants

CATSM

Global Headquarters4555 Riverside DrivePalm Beach Gardens, FL 334101-800-342-5454Outside The U.S.: +1-561-776-6700Fax: +1-561-776-1272www.biomet3i.com

ACT, Bone Bonding, CAM StructSURE, Certain, DIEM, Encode, EP, GingiHue, Gold-Tite, IOL, Miniplant, OSSEOTITE, OSSEOTITE XP, PreFormance,PREVAIL, Provide, QuickBridge, QuickSeat, STA and ZiReal are registered trademarks and ICE, MicroMiniplant, NanoTite and No-Touch are trademarks ofBIOMET 3i LLC. BIOMET is a registered trademark and BIOMET 3i and design are trademarks of BIOMET, Inc. ©2008 BIOMET 3i LLC. All rights reserved.

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