Clearance Summary
VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL received FDA 510(k) clearance under submission number K140350, sponsored by Preventive Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-12-12.
- Submission: K140350
- Applicant / Sponsor: Preventive Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 2014-12-12
Classification & Regulation
This clearance is catalogued under FDA product code LBH and 21 CFR 872.3260, within the Dental review panel as a Class II device.