Clearance Summary
BPA-FREE PIT AND FISSURE SEALANT received FDA 510(k) clearance under submission number K110058, sponsored by Novocol Inc. Dba Septodont and Confi-Dental Produc. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-03-31.
- Submission: K110058
- Applicant / Sponsor: Novocol Inc. Dba Septodont and Confi-Dental Produc
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 2011-03-31
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.