Last synced on 2 December 2022 at 11:04 pm

Powered Radiofrequency Toothbrush

Page Type
Product Code
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.
Physical State
The device is a handheld rechargeable powered toothbrush comprised of the handle, the brush head, and recharging unit. The brush head is designed with radiofrequency electrodes and bristles. The handheld unit contains the software, programming, and hardware necessary for the device to function. The device is operated by a push button for activation of the radiofrequency and vibration.
Technical Method
The device utilizes tactile vibration and low power conductive radiofrequencies to deliver vibration frequency and low power radiofrequency energy to the surface of the teeth to remove adhered plaque and food debris from the teeth.
Target Area
Oral cavity of the mouth
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.6866
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QMJ is linked to regulation 21CFR872.6866, which does not seem to exist yet. It may be pending at the moment.

Powered Radiofrequency Toothbrush

Page Type
Product Code
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.
Physical State
The device is a handheld rechargeable powered toothbrush comprised of the handle, the brush head, and recharging unit. The brush head is designed with radiofrequency electrodes and bristles. The handheld unit contains the software, programming, and hardware necessary for the device to function. The device is operated by a push button for activation of the radiofrequency and vibration.
Technical Method
The device utilizes tactile vibration and low power conductive radiofrequencies to deliver vibration frequency and low power radiofrequency energy to the surface of the teeth to remove adhered plaque and food debris from the teeth.
Target Area
Oral cavity of the mouth
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.6866
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QMJ is linked to regulation 21CFR872.6866, which does not seem to exist yet. It may be pending at the moment.