Clearance Summary
W&H HANDPIECE ANESTO, MODEL: RA-5 received FDA 510(k) clearance under submission number K083811, 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 2010-01-14.
- Submission: K083811
- Applicant / Sponsor: W&H Dentalwerk Buermoos GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4475
- Decision date: 2010-01-14
Classification & Regulation
This clearance is catalogued under FDA product code EGM and 21 CFR 872.4475, within the Dental review panel as a Class II device.