Clearance Summary
FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH received FDA 510(k) clearance under submission number K090597, sponsored by Pascal Co., Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-03-16.
- Submission: K090597
- Applicant / Sponsor: Pascal Co., Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 2009-03-16
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.