Clearance Summary
AURALAY PIT & FISSURE SEALANT received FDA 510(k) clearance under submission number K071158, sponsored by Denali Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-06-05.
- Submission: K071158
- Applicant / Sponsor: Denali Corporation
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 2007-06-05
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.