Clearance Summary
SMARTmatic received FDA 510(k) clearance under submission number K163239, 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 2017-03-17.
- Submission: K163239
- Applicant / Sponsor: Kaltenbach & Voigt GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2017-03-17
Classification & Regulation
This clearance is catalogued under FDA product code EFA and 21 CFR 872.4200, within the Dental review panel as a Class I device.