Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-96: ADA / ANSI ADA Specification No.30 -, Dental Zinc Oxide-Eugenol and Zinc Oxide Non-Eugenol Cements: 2000 (Reaffirmed 2005). (Dental/ENT)
Date of Standard: 2000. |
| Addresses of Standards Organizations: |
| American Dental Association (ADA) |
| 211 East Chicago Avenue |
| Chicago, IL 60611-2678 |
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| 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, PDP, IDE, HDE, Quality System Regulation |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes. Products do not have to meet the performance requirements in order to conform to the test methods listed in the 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 |
| §872.3275 |
Cement, Dental |
Class 2 |
EMA |
| |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff Dental Cements - Premarket Notification Document issued on: August 18, 1998 |
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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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