QMJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Powered Radiofrequency Toothbrush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.6866
- Medical specialty
- Dental
- FDA definition
- A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Silk’n Toothwave (K214078) | Home Skinovations , Ltd. | 2023-01-13 |
| ToothWave™ (DEN190039) | Home Skinovations , Ltd. | 2020-09-17 |
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Every clearance here is in the API, with alerts when new ones post.