Powered Radiofrequency Toothbrush

Home Skinovations Ltd.

The following data is part of a De Novo classification by Home Skinovations Ltd. with the FDA for Toothwave™.

Pre-market Notification Details

DeNovo IDDEN190039
Device Name:ToothWave™
ClassificationPowered Radiofrequency Toothbrush
Applicant Home Skinovations Ltd. tabor Building, Shaar Yokneam Yoqneam Illit,  IL 2069200
ContactAmit Goren
Product CodeQMJ  
CFR Regulation Number872.6866 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardDental
Classification AdvisoryDental
Date Received2019-08-22
Decision Date2020-09-17
Reclassification Order:Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases


Device IdentifiersubmissionNumberSupplement
07290112451675 DEN190039 000

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