Clearance Summary
The Cooral System received FDA 510(k) clearance under submission number DEN210027, sponsored by Braincool AB. The device was reviewed via the Direct premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-10-14.
- Submission: DEN210027
- Applicant / Sponsor: Braincool AB
- Clearance pathway: Direct
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5590
- Decision date: 2022-10-14
Classification & Regulation
This clearance is catalogued under FDA product code QUA and 21 CFR 872.5590, within the Dental review panel as a Class II device.