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QMJClass II

Powered Radiofrequency Toothbrush

21 CFR 872.6866 / Dental
FDA source (opens on fda.gov)

QMJ is the FDA product code for Powered Radiofrequency Toothbrush, a class II device type, regulated under 21 CFR 872.6866. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QMJ
Device name
Powered Radiofrequency Toothbrush
FDA 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.
Regulation
21 CFR 872.6866
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QMJ

By decision year
2 clearances under product code QMJ with a decision year between 2020 and 2023, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QMJ by decision year
YearClearances
20201
20231

Applicants with the most clearances

Product code QMJ
Applicants holding the most 510(k) clearances under product code QMJ
ApplicantClearances
Home Skinovations, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code