K214078 is an FDA 510(k) clearance for the Silk’n 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 Cleared decision on January 13, 2023, 382 days after receiving the submission on December 27, 2021.
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 | K214078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2021 |
| Decision Date | January 13, 2023 |
| Days to Decision | 382 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| 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. |