Clearance Summary
DURAGARD SODIUM FLUORIDE VARNISH received FDA 510(k) clearance under submission number K002581, sponsored by Sultan Dental Products, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-10-20.
- Submission: K002581
- Applicant / Sponsor: Sultan Dental Products, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 2000-10-20
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.