Clearance Summary
DEXIS CariVu 3-in-1 by KaVo received FDA 510(k) clearance under submission number K182712, 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 2019-11-23.
- Submission: K182712
- Applicant / Sponsor: Kaltenbach & Voigt GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1745
- Decision date: 2019-11-23
Classification & Regulation
This clearance is catalogued under FDA product code NTK and 21 CFR 872.1745, within the Dental review panel as a Class II device.