Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-157: ISO 3107 Third edition 2004-10-01, Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements - Third Edition. (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: |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| Vertical, International |
| 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 |
| §872.3275 |
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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