QMJ · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.6866
Classification
FDA Product Code
QMJ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.6866
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.