De Novo DEN210027
- Device
- The Cooral System
- Contact
- martin waleij
- De Novo number
- DEN210027
- Product code
- QUA
- Regulation
- 872.5590
- Classification name
- intraoral cooling device
- Decision
- granted (DENG)
- Decision date
- 2022-10-14
- Date received
- 2021-07-02
- Classification advisory
- Dental
- Review advisory
- Dental
- Type
- Direct
Current FDA Classification#
- Product code
- QUA
- Device name
- Intraoral Cooling Device
- Medical specialty
- Dental
- Device class
- 2
- Regulation
- 872.5590
- Implant
- N
- Life sustain/support
- N