Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-201: ISO 9693-2012, Dentistry -- Compatibility testing - Metal-ceramic systems. (Dental/ENT)
Date of Standard: 2012. |
| 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: |
| Base metal alloys, gold based alloys and preious metal alloys for clinical use, porcelain teeth, porcelain powder for clinical use, endosseous implant for prosthetic attachmenet |
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| Processes Affected: |
| 510(k), IDE, PMA, PDP, HDE, 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 |
| §872.3060 |
Alloy, Gold-Based Noble Metal |
Class 2 |
EJT |
| §872.3060 |
Alloy, Other Noble Metal |
Class 2 |
EJS |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3710 |
Alloy, Metal, Base |
Class 2 |
EJH |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3920 |
Teeth, Porcelain |
Class 2 |
ELL |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.6660 |
Powder, Porcelain |
Class 2 |
EIH |
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| Relevant Guidance: |
Guidance for Industry and FDA Staff Class II Special Controls
Guidance Document: Dental Nobel Metal Alloys Document issued on: August 23, 2004
Guidance for Industry and FDA Staff Class II Special Controls Guidance Document:
Dental Base Metal Alloys Document issued on: August 23, 2004
Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments Document issued on: May 12, 2004 |
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| FDA Technical Contacts: |
| Andrew Steen |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2604 |
| Silver Spring MD 20993 |
| 301/796-6284 |
| Email: andrew.steen@fda.hhs.gov |
|
| 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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