Clearance Summary
Air-Powered Handpieces and Handpiece Attachments received FDA 510(k) clearance under submission number K162926, sponsored by W&H Dentalwerk Burmoos 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 2017-02-23.
- Submission: K162926
- Applicant / Sponsor: W&H Dentalwerk Burmoos GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2017-02-23
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.