Clearance Summary
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT received FDA 510(k) clearance under submission number K012794, sponsored by Prime Dental Manufacturing, 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 2001-11-05.
- Submission: K012794
- Applicant / Sponsor: Prime Dental Manufacturing, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2001-11-05
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.