Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-150: ADA / ANSI Specification No.19, Dental - Elastometric Impression Material:2004. (Dental/ENT)
Date of Standard: 2004. |
| 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: |
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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: |
| National, Vertical |
| Extent of Recognition: |
| Complete standard. 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 |
| §872.3660 |
Material, Impression |
Class 2 |
ELW |
| |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff Dental Impression Materials - Premarket Notification Document issued on: August 17, 1998 |
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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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