Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-200: ISO 24234 First edition 2004-10-15, Dentistry -- Mercury and alloys for dental amalgam AMENDMENT 1. (Dental/ENT)
Date of Standard: 2011. |
| 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) | | DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID) |
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| (2) | OFFICE OF COMPLIANCE (OC) |
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| (3) | OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) |
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| (4) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), 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: |
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| Relevant Guidance: |
| Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy, July 28, 2009. |
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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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