Clearance Summary
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 received FDA 510(k) clearance under submission number K062886, sponsored by CAO Group, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-11-06.
- Submission: K062886
- Applicant / Sponsor: CAO Group, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 2006-11-06
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.