Clearance Summary
PACSEAL PIT & FISSURE SEALANT received FDA 510(k) clearance under submission number K141717, sponsored by Pac-Dent International, 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 2015-03-09.
- Submission: K141717
- Applicant / Sponsor: Pac-Dent International, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 2015-03-09
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.