De Novo DEN190039
- Device
- ToothWave™
- Contact
- amit goren
- De Novo number
- DEN190039
- Product code
- QMJ
- Regulation
- 872.6866
- Classification name
- powered radiofrequency toothbrush
- Decision
- granted (DENG)
- Decision date
- 2020-09-17
- Date received
- 2019-08-22
- Classification advisory
- Dental
- Review advisory
- Dental
- Type
- Direct
Current FDA Classification#
- Product code
- QMJ
- Device name
- Powered Radiofrequency Toothbrush
- Medical specialty
- Dental
- Device class
- 2
- Regulation
- 872.6866
- Implant
- N
- Life sustain/support
- N