QMJ — Powered Radiofrequency Toothbrush Class II

FDA Device Classification

Classification Details

Product Code
QMJ
Device Class
Class II
Regulation Number
872.6866
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K214078home skinovationsSilk’n ToothwaveJanuary 13, 2023
DEN190039home skinovationsToothWave™September 17, 2020