Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-126: ISO 10477 Second edition 2004-10-01, Dentistry - Polymer-based crown and bridge materials. (Dental/ENT)
Date of Standard: 2004. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| (2) | OFFICE OF COMPLIANCE (OC) | | |
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| Devices Affected: |
| Tooth shade resin material, temporary crown and bridge material |
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| Processes Affected: |
| 510(k), PMA, IDE, HDE, PDP, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard with amendment 1: Data from the test methods in the standard is needed. Additional testing may be necessary for some products. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3690 |
Material, Tooth Shade, Resin |
Class 2 |
EBF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3770 |
Crown And Bridge, Temporary, Resin |
Class 2 |
EBG |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions Document issued on: October 26, 2005 |
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| FDA Technical Contact: |
| Andrew Steen |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2604 |
| Silver Spring MD 20993 |
| 301/796-6284 |
| Email: andrew.steen@fda.hhs.gov |
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