Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-89: ADA / ANSI ADA Specification No.53, Polymer-Based Crowns and Bridge Resins:1999 (Reaffirmed 2008). (Dental/ENT)
Date of Standard: 1999. |
| Addresses of Standards Organizations: |
| American Dental Association (ADA) |
| 211 East Chicago Avenue |
| Chicago, IL 60611-2678 |
| |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
|
| (2) | OFFICE OF COMPLIANCE (OC) | | |
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| Devices Affected: |
| Tooth shade resin material, temporary crown and bridge material |
|
| Processes Affected: |
| 510(k), PMA, IDE, HDE, PDP, Quality System Regulation |
|
| Type of Standard: |
| National, Vertical |
| 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. |
|
| 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 |
| |
|
| Relevant Guidance: |
| Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions Document issued on: October 26, 2005 |
|
| FDA Technical Contact: |
| Michael Adjodha |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2606 |
| Silver Spring MD 20993 |
| 301/796-6276 |
| Email: michael.adjodha@fda.hhs.gov |
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