510(k) K080939
K080939 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoos GmbH for the device "SURGICAL HANDPIECES, MIKRO SAW HANDPIECES". The FDA issued a decision of Substantially Equivalent on July 29, 2008. The device falls under product code KMW (Handpiece, Rotary Bone Cutting), a Class II device regulated under 21 CFR 872.4120. W&H Dentalwerk Buermoos GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2008
- Date Received
- April 3, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Rotary Bone Cutting
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type