DEN190039 is an FDA 510(k) submission for the ToothWave™. This device is classified as a Powered Radiofrequency Toothbrush (Class II - Special Controls, product code QMJ).
Submitted by Home Skinovations , Ltd. (Yokneam, IL). The FDA issued a Not Cleared (DENG) decision on September 17, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6866. 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..
| 510(k) Number | DEN190039 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 22, 2019 |
| Decision Date | September 17, 2020 |
| Days to Decision | 392 days |
| Submission Type | Direct |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | QMJ - Powered Radiofrequency Toothbrush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6866 |
| 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. |