Clearance Summary
Provicol QM Plus received FDA 510(k) clearance under submission number K161630, sponsored by Voco 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 2016-09-15.
- Submission: K161630
- Applicant / Sponsor: Voco GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3275
- Decision date: 2016-09-15
Classification & Regulation
This clearance is catalogued under FDA product code EMB and 21 CFR 872.3275, within the Dental review panel as a Class I device.