The following data is part of a De Novo classification by Home Skinovations Ltd. with the FDA for Toothwave™.
| DeNovo ID | DEN190039 |
| Device Name: | ToothWave™ |
| Classification | Powered Radiofrequency Toothbrush |
| Applicant | Home Skinovations Ltd. tabor Building, Shaar Yokneam Yoqneam Illit, IL 2069200 |
| Contact | Amit Goren |
| Product Code | QMJ |
| CFR Regulation Number | 872.6866 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device 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 Board | Dental |
| Classification Advisory | Dental |
| Type | Direct |
| Date Received | 2019-08-22 |
| Decision Date | 2020-09-17 |
| 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 Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290112451675 | DEN190039 | 000 |