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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device powered radiofrequency toothbrush
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.
Product CodeQMJ
Regulation Number 872.6866
Device Class 2


Premarket Reviews
ManufacturerDecision
HOME SKINOVATIONS LTD.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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