Information on the product

Transcription

1 Information on the product Information on the product -Implantat.doc Page 1 of 15

2 This document composes of the following items 1. Name of the product 2. Raw materials 3. Structure and dimensions 3.1. External specific Fixture Cover screw 3.2. External appearance and structure Product picture and explanation of the fixture Product picture and explanations of the cover screw surface fixture surface cover screw 4. Fatigue Tests on Endosseous Dental Implants 5. Manufacturing process 5.1. Flowing chart of manufacturing process 5.2. Sterilization method 5.3. Package 6. Purpose of the product 7. Operating procedure 8. Test names, standards, methods and results Information on the product -Implantat.doc Page 2 of 15

3 1. Name of the product Artikel Nr. Name / Bezeichnung Medical device class Titanium screw implants Europa Material Implant S3,25 L8,5 2b TI Grade Implant S3,25 L10 2b TI Grade Implant S3,25 L11,5 2b TI Grade Implant S3,25 L13 2b TI Grade Implant S3,25 L15 2b TI Grade Implant S3,75 L8,5 2b TI Grade Implant S3,75 L10 2b TI Grade Implant S3,75 L11,5 2b TI Grade Implant S3,75 L13 2b TI Grade Implant S3,75 L15 2b TI Grade Implant S3,75 L18 2b TI Grade Implant S4,5 L7 2b TI Grade Implant S4,5 L8,5 2b TI Grade Implant S4,5 L10 2b TI Grade Implant S4,5 L11,5 2b TI Grade Implant S4,5 L13 2b TI Grade Implant S4,5 L15 2b TI Grade Implant S4,5 L18 2b TI Grade Implant S5,5 L8,5 2b TI Grade Implant S5,5 L10 2b TI Grade Implant S5,5 L11,5 2b TI Grade Implant S5,5 L13 2b TI Grade Implant Cover Screw S3,25 2b TI Grade Implant Cover Screw S3,75 2b TI Grade Implant Cover Screw S4,5 2b TI Grade Implant Cover Screw S5,5 2b TI Grade 4 Information on the product -Implantat.doc Page 3 of 15

4 2. Raw materials item Raw material name (Standard) Composition (%) Fe O N C H AL V Ti Implant Unalloyed titanium, Ti Gr4 (fixture) ASTM F67 0,5 0,4 0,05 0,1 0, Rest *Cover screw Unalloyed titanium, Ti Gr4 ASTM F67 Oxidized film : TiO 2 0,5 0,4 0,05 0,1 0, Rest * Any raw materials are not included in the color of the fixture head part. Color-coded : Each cover screw was color-coded by its diameter. Color code was added by electrical method, not by pigment addition. Change of the oxidized film through electrical method made its different colors of fixture head and cover screw. Table cover screw : diameter / color diameter colour Implant Cover Screw S3,25 green Implant Cover Screw S3,75 blue Implant Cover Screw S4,5 red Implant Cover Screw S5,5 yellow Information on the product -Implantat.doc Page 4 of 15

5 3. Structure and dimensions 3.1 External specification Fixture (1) diameter of fixture s platform : see implant overview S3,25-S5,5 (2) entire length of fixture : see implant overview S3,25-S5,5 (3) Fixture surface : Pure titanium (grade4) with an osteoconductive micro structured, uncoated surface (4) Shape of fixture : a) Internal thread for fixed-removable restorations b) Internal hex (2.5 mm Hex) to prevent rotation of the superstructure elements c) Internal cone design for perfect gap-free seating of the restorative components d) Optimal for maintaining good oral hygiene e) Narrow high-polish shoulder (5) Color code: The abutments for the fixture were color-coded for easy distinguishment. Color code was added by electrical method, not by pigment addition. Change of the oxidized film through electrical method made its different colors of the abutments. Information on the product -Implantat.doc Page 5 of 15

6 3.1.2 Cover screw (1) diameter of cover screw cap : 5.5mm, 4.1mm, 3.7mm (2) entire length of cover screw : 6.45mm, 5.8mm, 5,5mm (3) color code : Each cover screw has a color corresponding to the diameter of the implant which connect with. Implant size Implant S3,25 Implant S3,75 Implant S4,5 Implant S5,5 Color of the cover screw green blue red yellow Information on the product -Implantat.doc Page 6 of 15

7 3.2 External appearance and structure Product picture and explanations of the fixture Prosthetic connection Narrow high-polish shoulder Surface characteristics Information on the product -Implantat.doc Page 7 of 15

8 3.2.2 Product picture and explanations of the cover screw Each cover screw has a color corresponding to the diameter of the implant which connect with. Implant size Implant S3,25 Implant S3,75 Implant S4,5 Implant S5,5 Color of the cover screw green blue red yellow Information on the product -Implantat.doc Page 8 of 15

9 3.2.3 Surface Fixture Pure titanium (Grade 4) Surface osteoconductive microstructure Surface uncoated Measured mean surface roughness of 4 µm Surface produce with a special bio-inert material through a material-removing blasting technique Surface cover screw Pure titanium (Grade 4) Surface uncoated Oxidized titanium treatment Thickness of oxidized film : less than 10 μm 4. Fatigue Tests on Endosseous Dental Implants a. Test Report A4.2-44e/97 b. Test Report A4.2-45e/97 c. Test Report LB1.3-19e/2003 Precisely conditions and results are described in the annex. Implant size Load application Load profile Load angle Embedding deph Environment Test period Information on the product -Implantat.doc Page 9 of 15

10 5. Manufacturing process Information on the product -Implantat.doc Page 10 of 15

11 6. Purpose and Features of the product (1) Capability ~~~~~~ (2) Purpose on usage or effect Fixture for dental implant surgery 7. Operating procedure (1) Preparation before use See manual for Implant Surgery. (2) Operating procedure See instruction manual (3) Storage method after use Do not re-use. (3) Storage method and the period of validity(shelf life-caution) The SEMADOS-Implant must be kept dry, dark and at room temperature in their original Storage Container. The implants may not used after their dates of expiry indicated on the label. Packaging and Sterility The SEMADOS Implants come in a packaging system made up of following components (outside in): Storage container (box with product package insert) Sealed secondary packaging (hard plastic container with peel-off adhesive label for patient file Sterile primary packaging (glass) for implant and cover screw Shelf life The period of validity is 5 years. Information on the product -Implantat.doc Page 11 of 15

12 Picture of the packaging Information on the product -Implantat.doc Page 12 of 15

13 Product and packaging test method No Test method Period Standard 1 Sterilization of health care Routine ISO products -- Requirements for examination validation and routine control -- Radiation sterilization 2 Sterilization of health care products -- Radiation sterilization -- Substantiation of 25 kgy as a sterilization dose for small or infrequent production batches 3 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques Routine examination Routine examination ISO/TS DIN EN General requirements for the Routine competence of testing and examination calibration laboraties 5 Biological evaluation of medical Routine devices - Part 5: Tests for in vitro examination cytotoxicity (ISO :1999) 6 LAL-Test Routine Limulus amebocyte lysate (LAL) examination 7 Bioburden and Sterility Testing Routine examination DIN EN ISO/IEC ISO Information on the product -Implantat.doc Page 13 of 15

14 8. Test names, standards, methods, and results. Test Test name Test standard Test method # Test for Physical and mechanical features 1 Testing of material Chemical composition of the implant and the other X-Ray Photoelectron Spectroscopy (XPS) parts should be as Surface Microanalyses (EDX) claimed. 2 Bare eye Surface of products must Microscope and magnifier inspection be covered matt finish inspection only the shoulder of the implant should be high pollished. There must be no cracks and any defects on usage. And it do not have to be covered any alien substances 3 Packing Sealing part in the Bare eye inspection inspection packaging must be sealed up and keep the inner part from being infected. 4 Dimension test Dimensions must be as Measure with measuring shown in the drawings. apparatus (Microscope, micrometer, caliper) 5 Fatigue test No cracks and fractures Take an bending fatigue test must be shown through with using fatigue test microscope. And any apparatus. loosening problems do not have to occur. E.g. Load profile: sinus, pulsating load Upper load: 296N±3N Max N of cycles: 2x10 6 Load angle: 30 against Information on the product -Implantat.doc Page 14 of 15

15 implant axis Embedding depth: embedded until 3 mm below upper implant end Environment: Ringer`s solution, 37 C Test for biological features 1 Transplantation No inflammations and According to ISO test dead cells must be shown (1994) in tissue around test objects 2 Acute virulence Any abnormal reactions See above test must not occur in any case (Product and packaging test (not into oral: of test under the following method) I.V. route) conditions. -Observe it right after injection -After injection, observe it at an interval of 1, 3, 24, 48, 72 hours and 7 days. 3 Exothermicity test It must be suited to test pyrogen test method at the time of test See above (Product and packaging test method) 4 Cellular virulence It must be less than mild According to ISO test standard when the 5(1992) contrast between positivity See above and negativity is accurate. (Product and packaging test method) Information on the product -Implantat.doc Page 15 of 15