Miscellaneous devices · 21 CFR 872 Subpart G
Powered Radiofrequency Toothbrush
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.
- Companies listing it
- 11 makers
- Brands and models
- 1
- 510(k) clearances
- 21 in five years
- FDA name
- Powered Radiofrequency Toothbrush
510(k) clearances per year, 1976–2026
Companies that list QMJ
1 company currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Silk'n Beauty Ltd. | Netherlands | Maker | powered radiofrequency toothbrush | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 13 Jan 2023 | K214078 | Silkn Toothwave | Home Skinovations , Ltd. |
| 17 Sep 2020 | DEN190039 | ToothWave | Home Skinovations , Ltd. |
Official records: FDA product classification for QMJ · 21 CFR 872.6866.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026