Clearance Summary
SURGICAL HANDPIECES, MIKRO SAW HANDPIECES received FDA 510(k) clearance under submission number K080939, sponsored by W&H Dentalwerk Buermoos GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-07-29.
- Submission: K080939
- Applicant / Sponsor: W&H Dentalwerk Buermoos GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2008-07-29
Classification & Regulation
This clearance is catalogued under FDA product code KMW and 21 CFR 872.4120, within the Dental review panel as a Class II device.