Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-188: ISO 9917-2 Second edition 2010-04-15, Dentistry - Water-based cements - Part 2: Resin-modified cements. (Dental/ENT)
Date of Standard: 2010. |
| 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, HDE, PDP, QUALITY SYSTEM REGULATION |
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| Type of Standard: |
| Vertical, International |
| 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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