Clearance Summary
PIEZOMED received FDA 510(k) clearance under submission number K133488, 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 2014-10-16.
- Submission: K133488
- 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: 2014-10-16
Classification & Regulation
This clearance is catalogued under FDA product code DZI and 21 CFR 872.4120, within the Dental review panel as a Class II device.