SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
FDA 510(k) clearance K080939 · decided 2008-07-29
Clearance details
- K-number
- K080939
- Device name
- SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
- Applicant
- W&H Dentalwerk Buermoos GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-04-03
- Decision date
- 2008-07-29
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- KMW
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Buermoos, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30 recall (Z-1168-2024) | W&H DENTALWERK BUERMOOS GMBH | 2024-02-20 |