K080939 is an FDA 510(k) clearance for the SURGICAL HANDPIECES, MIKRO SAW HANDPIECES. This device is classified as a Handpiece, Rotary Bone Cutting (Class II - Special Controls, product code KMW).
Submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on July 29, 2008, 117 days after receiving the submission on April 3, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K080939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2008 |
| Decision Date | July 29, 2008 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KMW - Handpiece, Rotary Bone Cutting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |