SICHERHEITSDATENBLATT

Transcription

1 QUALITÄT BIORESORB PITT-EASY SICHERHEITSDATENBLATT Quality Assurance for SICHERUNG Sybron Implant Solutions s BICORTICAL QUALITÄTSSICHERUNGCYTOPLAST

2 Safety Data Sheet

3 PITT-EASY Safety Data Sheet for the Implant System PITT-EASY We, Sybron Implant Solutions GmbH, herewith confirm that we have introduced and applied a Quality Management System in the area of design, manufacture and final inspection of dental implants and accessories. This Quality Management System is in compliance with Annex II of the Council Directive 93/42/EEC concerning Medical Devices. It is also in compliance with the DIN EN ISO 13485:2003. The products listed below are registered with the CE-mark. Titanium Titanium Grade 4 Ball Head Abutment CAD/CAM-Base Direction Indicator Drilling Guides Healing Abutment (cylindrical and conical) Implant Cover Screw Implants Impression Coping (open and closed) Individual Abutment Metal Housing Implant Analog Paracentric Line Bar Element Paracentric Line Permucosal Extension Positioning Pins for drilling guides Standard Abutment, with hex Standard Abutment, without hex V.D.L. Esthetic Line

4 PITT-EASY Safety Data Sheet Titanium alloys Titanium Grade 5 Precious steel DIN DIN DIN DIN DIN DIN DIN DIN Centering Punch Retaining Screw Finger Key (version short and long) Hex Driver 1.70 mm (as hand instrument, for torque wrench or contra-angle) Implant Driver (version short and long) Hexagonal Adapter Implant Driver, latch type Lab Screw for individual abutment Ball Head Abutment Driver for contra-angle Scan Screw Titanium tweezers Reamer X-Ray Balls Osteometer Holding Pliers for instruments and implants Initial Perforation Drill Tissue Punch Cortical Drill Crestotom Drill Drill Extension Final Drill(s) Interspace Drill(s) Simultaneous Drill(s) Switch latch of torque wrench Twist Drill short and long Twist Drill special (for drilling guides) 2 Caliber Drill Cardanic Key Depth Gauge Finger Key for Implant Driver, 20 mm diameter

5 PITT-EASY DIN DIN DIN Precious metal alloy Novostil (cast-on) V-Gnathos supra Degulor M Acrylic PEEK POM VMQ 70 VMQ 75 FKM (Viton) Other Aluminum (1050A) Hand Grip for laboratory tool H.U.G.O. Driver Sleeve Torque wrench Sleeve Key (for torque wrench) Eco Kit Plus inlay Pilot Drill short and long Octagon Key (for torque wrench, as hand instrument) C.A.S. Novobase Abutment (base) Paracentric Line Bar Element Cerabond Line Abutment Bar, drop profile 25 mm CAD/CAM-Base Abutment A.G.T. Line Abutment C.A.S. Esthetic Abutment C.A.S. Novobase Abutment Casting Cap Paracentric Line Bar Element Root-Buffer Attachment (ball anchor) Plug for prosthetic key for torque wrench Trial Abutment (Abutment Trial Set) O-ring, red O-ring, blue O-ring for prosthetic key Kit

6 BICORTICAL Safety Data Sheet Safety Data Sheet for the Implant System BICORTICAL We, Sybron Implant Solutions GmbH, herewith confirm that we have introduced and applied a Quality Management System in the area of design, manufacture and final inspection of dental implants and accessories. This Quality Management System is in compliance with Annex II of the Council Directive 93/42/EEC concerning Medical Devices. It is also in compliance with the DIN EN ISO 13485:2003. The products listed below are registered with the CE-mark. Titanium Titanium Grade 4 Titanium Grade 5 Precious steel DIN DIN DIN DIN DIN DIN Bicortical Implants Ø mm and Model Analogs for square, round and ball head posts Metal Ringhousing Hexagonal adapter Post bending pliers (for square post) Initial Perforation Drill Twist Drill(s) Cardan Joint Key Depth Gauge(s) Extension for finger key and cardan joint key Finger Key Finger Key (for octagon key) Post bending stabilizer (for square post) Pilot Drill Octagon Key (for ball post)

7 BICORTICAL Acrylic POM VMQ 70 VMQ 75 Other Aluminium (1050A) Modelling/Impression Cap for square and round post O-ring, red O-ring, blue Tray

8 CYTOPLAST Safety Data Sheet Safety Data Sheet for Membranes CYTOPLAST We, Sybron Implant Solutions GmbH, herewith confirm that we have introduced and applied a Quality Management System for the medical product Cytoplast Resorb according to Annex II, Section 4, and for the medical product Cytoplast Non Resorb according to Annex V of the Council Directive 93/42 EEC concerning Medical Devices. It is also in compliance with the DIN EN ISO 13485:2003. The products listed below are registered with the CE-mark. Polymer Polytetrafluorethylene (PTFE) CYTOPLAST membrane Non Resorb

9 BIORESORB Safety Data Sheet for Bone Augmentation Material BIORESORB We, BIOVISION GmbH, herewith confirm that we have introduced and applied a Quality Management System in the area of design, manufacture and final inspection of ceramic bone replacement materials. This Quality Management System is in compliance with Annex II of the Council Directive 93/42 EEC concerning medical devices. It is also in compliance with the DIN EN ISO 9001 and DIN EN ISO 13485:2003. The products listed below are registered with the CE mark. Pure beta- Tricalcium phosphate Granule Size Ca 3 (PO 4 ) 2 without any BIORESORB bone augmentation material µm other component µm µm Pure beta- Tricalcium phosphate Ca 3 (PO 4 ) 2 without any BIORESORB Macro Pore µm other component bone augmentation material µm µm µm

10 Material Specifications We, Sybron Implant Solutions GmbH, herewith confirm that we have introduced and applied a Quality Management System in the area of design, manufacture and final inspection of dental implants and accessories. This Quality Management System is in compliance with Annex II of the Council Directive 93/42/EEC concerning Medical Devices. It is also in compliance with the DIN EN ISO 13485:2003. The products listed below are registered with the CE-mark. 10 Max. content in % of all substances Titanium Titanium Grade 5 Nitrogen N 0.05% (6AL4V) Carbon C 0.08% Hydrogen H 0.015% Ferrum Fe 0.4% Oxygen O 0.2% Vanadium V 3.5% 4.5% Aluminum AL 5.5% 6.75% Titanium Ti rest Titanium Grade 4 Nitrogen N 0.05% laut ASTM F Carbon C 0.10% Hydrogen H % Ferrum Fe 0.50% Oxygen O 0.40% Titanium Ti % Stainless Steel DIN Carbon C 1.17% 1.27% Chromium Cr 3.8% 4.5%

11 Stainless Steel Molybdenum Mo 4.7% 5.2% Vanadium V 2.7% 3.2% Wolfram W 6% 6.7% Nickel Ni 1% DIN Carbon C 0.42% 0.50% Silicon Si 1% Manganese Mn 1% Chromium Cr 12.5% 14.5% Nickel Ni 1% DIN Carbon C 0.18% 0.22% Silizium Si 1% Manganese Mn 1% Phosphor P 0.045% Sulfur S 0.030% Chromium Cr 12% 14% DIN Carbon C 0.13% 0.17% Silizium Si 1% Manganese Mn 1% Phosphor P 0.045% Sulfur S 0.030% Chromium Cr 12% 14% DIN Carbon C 0.42% 0.50% Silizium Si 1% Manganese Mn 1% Phosphor P 0.045% Sulfur S 0.030% Chromium Cr 12.5% 14.5% 11

12 12 Stainless Steel DIN Carbon C 0.6% 0.95% Silicon Si 1% Manganese Mn 1% Phosphor P 0.045% Sulfur S 0.030% Chromium Cr 17% 19% Molybdenum Mo 0.9% 1.3% Vanadium V 0.07% 0.12% Copper Cu 0.30% DIN Carbon C 0.2% 0.26% Silicone Si 1% Manganese Mn 2% Phosphor P 0.04% Sulfur S 0.15% 0.27% Chromium Cr 12.5% 14.5% Molybdenum Mo 1% 1.2% Nickel Ni 0.75% 1.1% DIN Carbon C 0.12% Silicon Si 1% Manganese Mn 2% Phosphor P 0,05% Sulfur S 0.15% 0.35% Chromium Cr 17% 19% Molybdenum Mo 0.7% Nickel Ni 8.0% 10% DIN Carbon C 0.03% Silizium Si 1% Mangan Mn 2% Phosphor P 0.04% Sulfur S 0.03%

13 Chromium Cr 17% 19% Nickel Ni 9.0% 11.0% DIN Carbon C 0.03% Silicon Si 1% Manganese Mn 2% Phosphor P 0.04% Sulfur S 0.03% Chromium Cr 17% 19% Nickel Ni 6.5% 9.0% DIN Carbon C 0.07% Silicone Si 1% Manganese Mn 2% Phosphor P 0.045% Sulfur S 0.03% Chromium Cr 18.5% Molybdenum Mo 2.0% 2.5% Nickel Ni 10.5% 13.5% Precious metal alloy Novostil Gold Au 59% 61% (HSL) Platinum Pt 23% 25% Palladium Pd 14% 16% Iridium Ir 0.8% 1.2% V-Gnathos supra Gold Au 85.5% 87.5% Platinum Pt 10.5% 12.5% Iridium Ir 0.05% 0.15% Zinc Zn 1.20% 1.60% Rhodium Rh 0.15% 0.25% Ferrum Fe 0.05% 0.15% Manganese Mn 0.05% 0.15% Tantalum Ta 0.05% 0.15% 13

14 Precious metal alloy Degulor M Gold Au 70% Platinum Pt 4.40% Palladium Pd 2.00% Iridium Ir 0.10% Silver Ag 13.50% Copper Cu 8.80% Zinc Zn 1.20% Acrylic 14 POM VMQ FKM PEEK Aluminum substance (Polyoxymethylene) (Vinyl-Methyl-rubber/Silicone) (Fluoric-rubber) (Polyetherketon) 1050A Silizium Si 0.25% Ferrum Fe 0.40% Copper Cu 0.05% Manganese Mn 0.05% Magnesium Mg 0.05% Zinc Zn 0.07% Titanium Ti 0.05% Aluminum Al 97.7%

15 PITT-EASY 15

16 Innovative s PITT-EASY BICORTICAL ENDOPORE BIORESORB CYTOPLAST Sybron Implant Solutions GmbH Julius-Bamberger-Straße 8a Bremen Germany Phone Fax info@sybronimplants.de : 06/08 - HDS5-02-GB