Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-137: ISO 6877 Second edition 2006-04-01, Dentistry - Root-canal obturating points. (Dental/ENT)
Date of Standard: 2006. |
| 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: |
| Root canal filling resin, gutta percha, endodontic silver points |
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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. 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 |
| §872.3820 |
Resin, Root Canal Filling |
Class 2 |
KIF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3840 |
Point, Silver, Endodontic |
Class 1 |
EKL |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3850 |
Gutta-Percha |
Class 1 |
EKM |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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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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