Clearance Summary
ESTETICA Dental Treatment Unit and Accessories received FDA 510(k) clearance under submission number K161488, sponsored by Kaltenbach & Voigt 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 2016-12-08.
- Submission: K161488
- Applicant / Sponsor: Kaltenbach & Voigt GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2016-12-08
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.