This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
3
TABLE OF CONTENTS
4 - 5COMPANY PROFILE
6IMPLANT SYSTEM8 - 13PCA IMPLANTS
14 - 15IMPLANT SURFACE
16 - 17PACKAGING
18 - 27SURGICAL TOOLS
28PROSTHETICS30HEALING CAPS
32IMPRESSION COPINGS
34STRAIGHT TITANIUM ABUTMENTS
36ANGULATED TITANIUM ABUTMENTS
38CASTABLE ABUTMENTS
40MULTI-UNIT ABUTMENTS
42SINGLE-UNIT ABUTMENTS
44BALL ABUTMENTS
4 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
Company Profile
Advanced Dental Solutions Ltd.The PALTOP group is based on more than 30 years ofexperience in the dental implantology field. Thecompany was established by three key individuals,who bring decades of experience in scientific research,dental surgery and implantology engineering.The PALTOP team has proven experience in internationalindustrial management to the highest standards.The company was founded by visionaries with the goalof establishing an international implant company thatwill lead the implant market by providing advanceddental solutions through scientific innovations,highly designed product development and state of artmanufacturing systems of the higheststandards and quality.
Company visionThe Company’s goal and Vision is to become a leadingcompany in providing advanced dental solutions inthe areas of implantology, restoration, esthetics andguided surgery technology.The company strives to spearhead these fields,combining international knowledge and experiencefrom the top of the clinical world, with fast anddynamic developmental systems. PALTOP has themost advanced production lines as well as marketdevelopment that is based upon world IT trends andsocial networks.
We Combine Biology And TechnologyThe company is based on:
§ Top level extensive medical experience § Top level quality and control systems § Top level engineering skills § Top level scientific know-how § Top level advanced manufacturing facilities § Experienced founders & management
Extensive medical experienceEngineering tradition
With you to the top!Quality customer service
5
COMPANY PROFILE
Dr. Michael Klein,Medical Director
Michael Klein, D.D.S. graduated from the University of Maryland Dental School. He went on to complete a General Practice Residency program at Woodhull Medical Center in Brooklyn, New York. Dr. Klein received his training in Oral Implantology by completing a two year, full-time Fellowship in Oral Implantology and Biomaterials at the Brookdale Hospital Medical Center in Brooklyn, New York. He then completed Specialty training in Prosthodontics at the University of Medicine and Dentistry of New Jersey.
Dr. Klein was a Clinical Associate Professor at New York University College of Dentistry in the Department of Periodontology and Implantology for 17 years. Dr. Klein is a Diplomate of the American Board of Oral Implantology/Implant Dentistry. He is a Diplomate of the International Congress of Oral Implantology (ICOI). He is a Fellow of the Academy of Osseointegration and a Fellow of the Greater New York Academy of Prosthodontics. He has pioneered the technology used in computer guidance for dental implant surgery and holds multiple patents for this technology. Dr. Klein founded Implant Logic Systems, a commercial leader in the development of technology, software and hardware for computer guided dental implant surgical procedures. Dr. Klein successfully sold the company to BioHorizons Implant Company in 2008. Dr. Klein is the Director of Advanced Implant Dentistry and Oral Restoration in Cedarhurst, New York, where he maintains a private practice limited to Prosthodontics and Oral Implantology. He has co-authored a book, The Atlas of Oral Implantology, as well as numerous book chapters and articles on Implant Dentistry. Dr. Klein speaks nationally as well as internationally on a variety of topics in Oral Implantology.
Mr. Sam Topaz,CEO
B.A. in Economics & Business Managment and Advanced Managment studies in Harvard University, Boston, USA. Mr. Topaz offers 34 years experience of international industrial management, marketing and global distribution.
Mr. Topaz was the CEO of HAM-LET Group for over three decades and lead it from a family business to a public global company operating through fully owned subsidiaries all over the world.
Mr. Topaz brings to PALTOP ® extensive experience in technological development, establishment of advanced production systems, and setting up advanced global distribution networks, that include subsidiaries and computerized logistic centers that coordinate on-line between the development, production and sales departments.
Mr. Shlomo Hillel,R&D Manager
Mr. Hillel served as Sales Manager and Technical Advisor at one of the world's five leading companies in the dental implant field. Mr. Hillel is a master dental technician, CDT, with experience of over 20 years in the dental field.
Dr. Gil Asfrana,B.M.Sc, D.M.D
Oral Rehabilitation Specialist. Head of Prosthodontics Unit at Hospital Rabin Belinson Head Doctor at Private Dental Clinic, Faculty member at Tel Aviv University. Lecturer at the Prosthodontics, Post Graduate course, Tel Aviv University, Lecturer world wide.
6 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
1. Retention:The closer the tolerance between the implant angle (α)
to the abutment angle (β) the greater the mechanical retention
for eliminating micro movement.
2. Sealing against bacterial endotoxin leakage:The larger the angle (α), the better the seal.
Group A companies: 8≤ α ≤ 16 - good friction (retention)
Group B companies: 16≤ α ≤ 30 - good sealing*
3. Material specifications:Superior material mechanical properties enable engineering possibilities to design a better seal.
4. One Platform:Minimizes the number of prosthetic connections while providing optimal prosthetic options.
* Harder S, Dimaczek B, Açil Y, Terheyden H, Freitag-Wolf S, Kern M.
(2009), Molecular leakage at implant abutment connection.
Important factors in the design of a conical implant abutmentconnection
7
IMPLANT SYSTEM
The PALTOP AdvantageThrough an understanding of biology, engineering, materials, science and practical clinical usage, the PALTOP Conical Connection was developed.
1. The Paltop implant angle (α) and the abutment angle (β) are produced to accuracy of 0.5° to achieve excellent retention and zero micro movement.
2. The Paltop 22° conical angle creates an optimal seal against bacterial endotoxin leakage. while maintaining excellent retention.
3. The Implant and abutment material is Titanium alloy Grade 5 which has superior mechanical properties to pure titanium.
4. Uniform Platform :
• Implant diameters are 3.25, 3.75, 4.2 and 5.0mm. • One prosthetic platform which reduces parts in
stock and avoids confusion and mistakes.
• Prosthetic range is available for cemented and screw retained restorations.
• A unique range of prosthetic parts allowing for esthetic results with two different emergence profiles - standard (4.5mm) and wide. (6.0mm)
5.0mm 4.2mm 3.25mm3.75mm
8 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
A
B
C
D
E
PALTOP PCA
Platform shifting and platform switching enables soft tissue to grow, minimizes bone resorption and creates the optimal aesthetic result.
Micro threads to reduce bone stresses and minimize bone resorption.
Cylindrical profile for bone compression and initial stability.
Easy insertion with cutting thread.
Active apex that allows easy insertion and correction possibility for the implant depth.
The Paltop Conical Implant has all the advantages of the Paltop Advanced implant System. The development of the PALTOP conical implant is a result of our 5 years of success with the PALTOP Advanced Dental Implant combined with the introduction of a unique conical connection design.Paltop’s unique geometrical implant body design and thread profile increases initial stability and promotes bone healing.
Paltop Surface TreatmentFor fast and robust osseointegration, the PALTOP implants are treated with state of the art surface treatment procedures.
PALTOP’s surface treatment, consisting of sand-blasting, acid etching and extensive cleaning, achieves the
desirable outcome of a
highly cleaned and safe implant surface with ideal morphology for accelerated integration, initial stability and long term bone healing.
Surfaces
The success of dental implants is based on a process known as osseointegration, which occurs when bone cells attach themselves directly to the titanium surface, essentially locking the implant into the jaw bone.
The osseointegration rate of titanium dental implants is associated with their composition and surface morphology. Rough-surfaced implants favor both bone anchoring and biomechanical stability.
PALTOP implants are treated with state of the art surface treatment procedures. This treatment creates macro, micro and nano surface structures, enlarging the Bone to Implant Contact (BIC), thus enabling fast osseointegration and early restoration.
PALTOP’s surfaces promote bone healing leading to the rapid biological fixation of the implant.
15
IMPLANT SYSTEM IMPLANT SURFACE
Rough SurfacesPALTOP’s surface treatment processes of sand blasting followed by acid etching increases the outer envelope area of implant, thereby enlarging the bone-implant interface area.
PALTOP’s high performance surface treatment process creates macro, micro and nano surface structure, that are ideal topography for osseointegration.
The derived surface morphology promotes initial stability and long term bone healing.
Clean SurfacesThe success and safety of dental implants is very much influenced by the surface composition. PALTOP’s multi-stage extensive cleaning process removes undesired residues derived from processing, yielding a contamination-free surface.
PALTOP’s cleaning process enerates a stable titanium-oxide layer that chemically stabilizes the implant surface. The layer’s optimal thickness, of 3-4 nm, attracts body fluids without concealing surface morphology, thus promoting bone healing.
A process for obtaining surface cleanliness following protocols and standards of
the semi-conductor industry has been extensively developed and tested by PALTOP and applied on PALTOP Advanced and PALTOP Conical implants. Testing was done with XPS standard, XPS bulk, SEM (50x for general view of contamination, and 1000x and 5000x for the microstructure of the upper implant layer), and EDS. These tests of the highest standards are routinely used by protocol and schedule to ensure that the processes developed are maintaining the highest surface purity.
IMPLANT SYSTEM
16 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
PALTOP implants are packaged in our ISO Class 7 Clean Room. The implants are supplied in a sealed vial (tube), in order to prevent any contamination on the implant’s surface. The implant is inserted into the vial and does not touch any other material other than titanium.
The implant packaging is very comfortable for the user conveniencer. The implant can be easily pulled out of the titanium sleeve in which it is positioned. The cover screw is positioned inside the lid that seals the tube. This is for users convenience and in order to comply to standard procedures. The implant is mountless and is pulled out using a key, ratchet adaptor or motor.
MARLEX® 9006Polyethylene
Titanium Alloy Ti 6AI4V ELI
STYRON 637Polystyrene
sticker
onlyPx
2STERILIZE
STERILE R
Do not reuse
Do not resterilize
Do not use if packageis damaged
Sterilized using gamma radiation
Ø4.
2 • L
11.
5
LOT
WO
W-1
2345
6R
EF20
-700
08
PALT
OP
PCA
Ø4.
2 • L
11.
5
LOT
WO
W-1
2345
6R
EF20
-700
08
PALT
OP
PCA
LOT WOW-123456
Ø4.2 • L 11.5REF 20-70008
PALTOP PCA DENTAL IMPLANT
Manufactured byPaltop Advanced Dental
Solutions LTD.Hashita 5, P.O Box 3568Caesarea 30889 • Israel
The package is designed with a number of indications that ensure fast and reliable product identification:
§ Lid color indication – four colors represent different diameters: red, blue, green, and gold.
§ The label on the tube’s lid indicates the implant’s diameter and length.
§ A product characterization label is positioned outside the implant’s outer tube.
PACKAGING
§ PALTOP uses sterile blister packaging for protecting prosthetic components and tools.
§ PALTOP’s blister packaging was specially developed to provide ultimate protection for PALTOP’s components and to enable gamma sterilization.ANATOMIC CONCAVE ANGULATED ABUTMENTS
The Basic Kit:This kit has a smaller tray that can be sterilized in all sizesof sterilizers. The full range of PALTOP implants can beperformed with the basic kit
Basic kit - cat # 60-70110
19
SURGICAL TOOLS
Drill extender 60-70019 1
2.5 hex Manual driver for ratchet 60-70009 1
2.0 hex Manual driver for ratchet 60-70012 1
1.25 short manual driver 60-70005 1
Parallel pin 1.5-2.0mm 60-70015 2
Pilot drill (spade) 60-70020 1
1.5/2.0 mm long drill 60-70048 1
2.0/2.4 mm long drill 60-70050 1
2.4/3.2 mm long drill 60-70052 1
3.2/3.8 mm long drill 60-70054 1
Final drill for 3.25 mm implant 60-70035 1
Final drill for 3.75 mm implant 60-70037 1
Final drill for 4.2 mm implant 60-70039 1
Final drill for 5.0 mm implant 60-70041 1
Ratchet 60-70013 1
Com
pact
kit
The Compact Kit:This kit has the minimum number of toolsneeded to place all PALTOP implants
compact kit - cat # 60-70111
SURGICAL TOOLS
20 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
Ratchet 60-70013 1
Drill Depth Probe 60-70073 1
Hand Piece 60-70014 1
Drill Stop Kit 60-70200 1
Prem
ium
kit Key Ratchet adapter 60-70100 2
Drill extender 60-70019 1
Long 1.25 Hex key 60-70101 1
Short 1.25 Hex key 60-70102 1
Long 2.5 Hex key 60-70103 1
Short 2.5 Hex key 60-70104 1
Long 2.0 Hex key 60-70105 1
Short 2.0 Hex key 60-70106 1
Parallel pin 1.5-2.0mm 60-70015 4
Pilot drill (spade) 60-70020 1
1.5/2.0 mm long drill 60-70048 1
1.5/2.0 mm short drill 60-70047 1
2.0/2.4 mm long drill 60-70050 1
2.0/2.4 mm short drill 60-70049 1
2.4/3.2 mm long drill 60-70052 1
2.4/3.2 mm short drill 60-70051 1
3.2/3.8 mm long drill 60-70054 1
3.2/3.8 mm short drill 60-70053 1
Final drill for 3.25 mm implant 60-70035 1
Final drill for 3.75 mm implant 60-70037 1
Final drill for 4.2 mm implant 60-70039 1
Final drill for 5.0 mm implant 60-70041 1
21
SURGICAL TOOLS
The Premium Kit has these additions to the Basic kit:
Larger tray that allows easier access to the tools. Short twist drills that allow easier access to areas with
limited inter-arch space. Drill stops for all PALTOP implant diameters and lengths to help the doctor verify
the depth of the osteotomy. Probe to measure the depth and check the osteotomy walls.
Premium kit - cat # 60-70112
SURGICAL TOOLS
22 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
Ost
eoto
mek
it
The Osteotome KitIt is well established that good primaryimplant stability is critical to predictableosseointegration.This stability depends upon different factors.These factors include implant design andsurgical protocol, but above allbone quantity and quality.There are some clinical situations in whichthe bone quality is so poor that good implantstability is difficult to obtain.
The threaded design of thePALTOP osteotome creates bonecompression and osteotomypreparations atraumaticaly.The conventional osteotometechnique of using a mallettotap the osteotome has been associated with benignpar oxysmal positional vertigo(BPPV).
The PALTOP Osteotome Kitallows you to improve stabilityin poor quality bone. Osteotomekit includes four osteotomes forall PALTOP implants sizes. The screw-type osteotomes areused for such purposes as bonecompression and bone expansion.
It is important to match the sizeof the osteotome to the implantdiameter. This will help ensurethe stability of the implant inall types of bone and anatomicconsiderations.The PALTOP Osteotome Kit isdesigned for all PALTOP implantbody diameters. The osteotomedesign createsbone compressionwith precise osteotomypreparation. Easy insertionand predictable initial stabilityare the result of the PALTOPosteotome design.
A B C D
A osteotome for 3.25 implant - Cat. # 60-70081B osteotome for 3.75 implant - Cat. # 60-70082C osteotome for 4.2 implant - Cat. # 60-70083
D osteotome for 5.0 implant - Cat. # 60-70084
23
SURGICAL TOOLS
Surgical Drilling Sequences
High Torque ReliefPALTOP implants are designed for immediate loading.
In case of high insertion torque PALTOP recommends the “High Torque Relief” procedure.
All recommended procedures by PALTOP cannot replace the surgeon's judgment and experience.
The recommended protocol by PALTOP cannot replace the surgeon's judgment and experience.
Soft Bone
Soft Bone
Soft Bone
Soft Bone
pilot drill
pilot drill
pilot drill
pilot drill
finalØ 4.2
finalØ 4.2
Ø 3.8---------Ø 3.2
Ø 2.0---------Ø 1.5
Ø 2.0---------Ø 1.5
Ø 2.0---------Ø 1.5
Ø 2.4---------Ø 2.0
Ø 2.4---------Ø 2.0
Ø 3.2---------Ø 2.4
Dense Bone
High Torque
finalØ 5.0
finalØ 5.0
optional
Dense Bone
High Torque
finalØ 3.75
finalØ 3.75
Dense Bone
High Torque
finalØ 3.25
optional
Dense Bone
Ø 4.20mm
Ø 5.0mm
Ø 3.75mm
Ø 3.25mm
OPTIONALDrilling sequence may begin with
drill Ø 2.4 / Ø 2.0
*
*
*
*
Ø 2.0---------Ø 1.5
Ø 2.4---------Ø 2.0
Ø 3.2---------Ø 2.4
optional
optional
6mm
6mm
6mm
SURGICAL TOOLS
24 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
The PALTOP Drill Stop Kit is designed to simplify the drilling
process and save valuable chair time. It enables the doctor
to drill the exact desired depth with safety and confidence..
One Simple drill Stop Kit For All Implant Dimensions
Only 12 Sleeves Needed to Fit All Implants of all Diameters
Drilling ProcedurePALTOP ensures a simple drilling procedure wherethe protocol is intuitively presented by colors.Each color is associated with a different implantdiameter and leads the doctor step by step to asafe and perfectly sized osteotomy.
Tool VersatilityEvery tool can be used by motor (contra angle), handtool or ratchet, and enables conversion from oneapplication to the other. All tools are designed withprecision to assure their expected performance in all3 tasks.
Motor Hand
HEX KEY
Ratchet
Step DrillsEach drill leads to the next one for fast andaccurate drilling. Step drilling is the fastest andmost accurate way to drill.PALTOP presents specially designed step drills withdimensions and shapes to best match the shapeof our implnts and with optimized cutting edges toachieve optimal drilling.
Welcome to the new world of
Simplicity
27
Prosthetics
PROSTHETICS
28 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
29
PROSTHETICS
CONCAVEDESIGN
High estheticsThe unique concave design enables the mucosal tissue to form a dense layer surrounding the trans-gingiva interconnection. This results in reduced tissue transparency and decreases visual appearance of metal.
Enhanced gingiva healingThe innovative design creates an optimal emergence profile, enabling replacement of temporary prosthetics with fixed prosthetics without harming the newly formed tissue structure. This reduces the trauma to the implantation site and accelerates the healing process.
Table of screw setting torque (N-cm)
Prosthesis torque (N-cm)
Healing cap 15
Multi-Unit abutments 30
Single-Unit abutments 30
Ball abutments 25
Multi-Unit screw 25
Single-Unit screw 25
Abutment screw 25
30 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
HEALING CAPS
31
PROSTHETICS
2mm 3mm 5mm 7mm
Ø 4.5 mm
55-72042 55-72043 55-72045 55-72047
Ø 6.0 mm
55-72062 55-72063 55-72065 55-72067
HEALING CAPS
PROSTHETICS
32 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
CLASSIC OPEN TRAY PROCEDURE
CLASSIC CLOSED TRAY PROCEDURE
impression copings
33
PROSTHETICS
Impression Coping
56-72145
Impression Coping
56-72160
Impression Coping
56-72045
Impression Coping
56-72060
CLASSIC OPEN TRAY PROCEDURE
CLASSIC CLOSED TRAY PROCEDURE
Analog
56-72011
impression copings
Ø 4.5 mm
Ø 6.0 mm
PROSTHETICS
34 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
PALTOP Titanium abutments are made of 6% Aluminum and 4% Vanadium, This Titanium is the most common type of titanium used in medicine and biomedical applications. Due to its harmonizing factor with the human body, this titanium alloy is popularly used in medical procedures.It’s biocompatibility makes this raw material ideal for dental applications. Ti 6Al-4V ELI combines high fatigue strength, low weight, excellent corrosion resistance, and high toughness. PALTOP offers an expanded collection of titanium prosthetic components for a widerange of prosthetic applications.
Straight titaniumabutments
35
PROSTHETICS
1mm 2mm 3mm 4mm 5 mm
ST
RA
IGH
T
CONCAVE ABUTMENT Ø 4.5 mm
40-72041 40-72042 40-72043 40-72044 40-72045
CONCAVE ABUTMENT
Ø 6 mm
40-72061 40-72062 40-72063 40-72064 40-72065
STRAIGHT
40-72010
STRAIGHT TITANIUM ABUTMENTS
Straight titaniumabutments
PROSTHETICS
36 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
Angulated TitaniumAbutments
37
PROSTHETICS
KNIFE EDGE
20°
40-72020
1mm 2mm 3mm 4mm 5mm
20°ANATOMIC
ANGULATED ABUTMENTS
40-72241 40-72242 40-72243 40-72244 40-72245
ANGULATED TITANIUM ABUTMENTS
Angulated TitaniumAbutments
PROSTHETICS
38 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
Engage
Ca
sta
ble
ab
utm
en
t
46-72001
Non Engage
46-72002
Titanium base for individual crown
Eng
age
40-72031
No
n E
ngag
e
40-72032
PALTOP offers an expanded product line of custom abutments.These custom parts are intended for use by the dental technician forconstructing prosthetic restorations.
Custom
Custom Abutments
39
PROSTHETICS
Engage Non Engage
Tem
po
rary
a
bu
tme
nt
45-72031 45-72032
Temporary
Temporary Abutments
PROSTHETICS
40 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
Multi-Unit
41
PROSTHETICS
Healing Cap Titanium Castable
55-72010 42-70020 42-70021
Closed Tray Impression
Coping
56-72003
Open Tray Impression
Coping
56-72002
Analog
56-72001
ANGULATED MULTI-UNIT
MULTI UNIT
1mm 2mm 3mm 4mm 5mm
42-72041 42-72042 42-72043 42-72044 42-72045
17° 30°
42-72017 42-72030
PROSTHETICS
42 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
Single-Unit
43
PROSTHETICS
TAT-TAT-KOTERET
1mm 2mm 3mm 4mm 4mm
43-72041 43-72042 43-72043 43-72044 43-72045
Closed Tray Open Tray Abutment Analog
56-70021 56-70023 56-70022
Castable Healing Cap Titanium
41-70057 55-70012 41-70056
SINGLE-UNIT
PROSTHETICS
44 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
Ball Abutments
45
PROSTHETICS
Analog Nylon Nylon Pink Metal Case
56-70013 40-70065 40-70023 40-70022
1mm 2mm 3mm 4mm 5mm
40-72001 40-72002 40-72003 40-72004 40-72005
BALL ABUTMENTS
REGULATION AND QUALITY SYSTEM
46 PALTOP ADVANCED DENTAL SOLUTIONS LTD.
It is the policy of PALTOP® to provide quality products and services that consistently meet the needs and expectations of our customers and the regulatory requirements of the medical industry. Our objective is to be the leaders in both technology and quality.
In order to be leaders in the field of dental implantology solutions and to enhance customer satisfaction when using the products, PALTOP’s management is committed to:
n Developing and implementing quality management systems that comply with the internal as well as statutory and regulatory requirements.
n Ensuring comprehension and involvement in PALTOP’s quality goals and quality policy.
n Creating an atmosphere that will influence PALTOP employees, suppliers and consultants to initiate changes that improve PALTOP products.
n Maintaining the effectiveness of PALTOP’s products, services and quality in order to enhance customer satisfaction and to become the leaders in the field.
n Discovering ways of expanding PALTOP’s technology into different fields or applications.