Clearance Summary
FISSURE SEALER & BONDING AGENT received FDA 510(k) clearance under submission number K813091, sponsored by Sci-Pharm, 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 1981-11-24.
- Submission: K813091
- Applicant / Sponsor: Sci-Pharm, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 1981-11-24
Classification & Regulation
This clearance is catalogued under FDA product code EBC and 21 CFR 872.3765, within the Dental review panel as a Class II device.