Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-189: ISO 10139-1:2005 Technical Corrigendum 1 2006-03-01, Dentistry - Soft lining materials for removable dentures - part 1; Materials for short-term use. (Dental/ENT)
Date of Standard: 2005. |
| 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), IDE, PMA, PDP, HDE, Quality System Control |
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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 |
| §872.3760 |
Resin, Denture, Relining, Repairing, Rebasing |
Class 2 |
EBI |
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| Relevant Guidance: |
| Guidance for Industy and FDA Staff OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits, Doucment 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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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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