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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name powered radiofrequency toothbrush
De Novo Number DEN190039
Device Name ToothWave™
Requester
Home Skinovations Ltd.
tabor building, shaar yokneam
yoqneam illit,  IL 2069200
Contact amit goren
Regulation Number872.6866
Classification Product Code
QMJ  
Date Received08/22/2019
Decision Date 09/17/2020
Decision granted (DENG)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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