Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-91: ADA / ANSI ADA Specification No.80 2001 (Reaffirmed 2007), Dental Materials - Determination of Color Stability. (Dental/ENT)
Date of Standard: 2007. |
| 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 |
| |
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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: |
| Artificial teeth, porcelain teeth, artificial teeth with metal insert, crown and bridge temporary resin, tooth shade resin material, denture relining and repair resin |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Quality System Regulation |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes. Data from the test methods in the standard is needed. Additional testing is necessary for most 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 |
| §872.3760 |
Resin, Denture, Relining, Repairing, Rebasing |
Class 2 |
EBI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3770 |
Crown And Bridge, Temporary, Resin |
Class 2 |
EBG |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3900 |
Teeth, Artificial, Posterior With Metal Insert |
Class 1 |
ELJ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3910 |
Teeth, Artificial, Backing And Facing |
Class 1 |
ELK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3920 |
Teeth, Porcelain |
Class 2 |
ELL |
| |
|
| 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: |
| 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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