FDA product code QMJ: Powered Radiofrequency Toothbrush
QMJ is the FDA product code for powered radiofrequency toothbrush. It is a Class II device, regulated under 21 CFR 872.6866 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under QMJ, 1 in the last five years. The average 510(k) review took 382 days (median 382). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Powered Radiofrequency Toothbrush |
| Device class | Class II |
| Regulation | 21 CFR 872.6866 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for QMJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 382 |
Compare with all 510(k) review times · Search every QMJ clearance
Top QMJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Home Skinovations , Ltd. | 1 | 2023-01-13 |
Most recent QMJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K214078 | Home Skinovations , Ltd. | Silkn Toothwave | 2023-01-13 | 382 |
Recalls for QMJ devices
openFDA lists no recalls for product code QMJ.
Frequently asked questions
What is FDA product code QMJ?
QMJ is the FDA product code for powered radiofrequency toothbrush. It is a Class II device, regulated under 21 CFR 872.6866 and reviewed by the Dental panel.
What device class is QMJ?
Class II, regulation 21 CFR 872.6866. Typical premarket route: 510(k).
How long does a 510(k) take for product code QMJ?
Across 1 cleared submissions the average was 382 days from receipt to decision (median 382).
Which companies have the most QMJ clearances?
Home Skinovations , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QMJ
- Run a recall and safety report across every QMJ manufacturer
- Watch product code QMJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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