QMJ · Class II · 21 CFR 872.6866

FDA Product Code QMJ: 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.

Leading manufacturers include Home Skinovations , Ltd..

2
Total
1
Cleared
387d
Avg days
2020
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Powered Radiofrequency Toothbrush Devices (Product Code QMJ)

2 devices
1–2 of 2
Cleared Jan 13, 2023
Silk’n Toothwave
K214078
Home Skinovations , Ltd.
Dental · 382d
Not Cleared Sep 17, 2020
ToothWave™
DEN190039
Home Skinovations , Ltd.
Dental · 392d

About Product Code QMJ - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QMJ since 2020, with 1 receiving FDA clearance (average review time: 387 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QMJ devices are reviewed by the Dental panel. Browse all Dental devices →