Clearance Summary
CLEAR BRAVO received FDA 510(k) clearance under submission number K083473, sponsored by Denali R&D 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 2009-01-22.
- Submission: K083473
- Applicant / Sponsor: Denali R&D Corporation
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 2009-01-22
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.