DEN210027 is an FDA 510(k) submission for the The Cooral System. This device is classified as a Intraoral Cooling Device (Class II - Special Controls, product code QUA).
Submitted by Braincool AB (Lund, SE). The FDA issued a Not Cleared (DENG) decision on October 14, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5590. An Intraoral Cooling Device Is A Prescription Use Device That Is Intended To Cool The Mouth For Patients At Risk For Oral Mucositis. An Intraoral Cooling Device Consists Of A Removable Mouthpiece And Accessories That Cool Oral Mucosal Surfaces.
| 510(k) Number | DEN210027 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 02, 2021 |
| Decision Date | October 14, 2022 |
| Days to Decision | 469 days |
| Submission Type | Direct |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | QUA - Intraoral Cooling Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5590 |
| Definition | An Intraoral Cooling Device Is A Prescription Use Device That Is Intended To Cool The Mouth For Patients At Risk For Oral Mucositis. An Intraoral Cooling Device Consists Of A Removable Mouthpiece And Accessories That Cool Oral Mucosal Surfaces |