Product code QMJ

Device name

Powered Radiofrequency Toothbrush

Medical specialty

Dental

Device class

2

Regulation number

872.6866

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset