Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-76: ISO 7785-2 Second edition 1995-08-01, Dental handpieces -- Part 2: Straight and geared angle handpieces. (Dental/ENT)
Date of Standard: 1995. |
| 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: |
| Straight and geared angle handpieces |
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| Processes Affected: |
| 510(k), PMA, IDE, HDE, PDP |
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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 |
| §872.4120 |
Handpiece, Rotary Bone Cutting |
Class 2 |
KMW |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.4200 |
Controller, Foot, Handpiece And Cord |
Class 1 |
EBW |
| §872.4200 |
Handpiece, Air-Powered, Dental |
Class 1 |
EFB |
| §872.4200 |
Handpiece, Belt And/Or Gear Driven, Dental |
Class 1 |
EFA |
| §872.4200 |
Handpiece, Contra- And Right-Angle Attachment, Dental |
Class 1 |
EGS |
| §872.4200 |
Handpiece, Direct Drive, Ac-Powered |
Class 1 |
EKX |
| §872.4200 |
Handpiece, Water-Powered |
Class 1 |
EKY |
| |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff Dental Handpieces - Premarket Notification [510(k)] Submissions Document issued on: May 2, 2007 |
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| FDA Technical Contact: |
| Sheena Green |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2540 |
| Silver Spring MD 20993 |
| 301/796-6279 |
| Email: sheena.green@fda.hhs.gov |
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