Powered Radiofrequency Toothbrush
The Powered Radiofrequency Toothbrush is a dental device consisting of a handle containing a radiofrequency generator that delivers radiofrequency energy to a brush applied to the teeth, intended to remove adherent plaque and food debris to reduce tooth decay. It is a powered oral hygiene device distinguished from conventional electric toothbrushes by its use of radiofrequency energy. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 872.6866 in the Dental specialty. It carries product code QMJ and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QMJ
- Device Class
- FDA class 2
- Regulation Number
- 872.6866
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.