K223338 is an FDA 510(k) clearance for the Toothsi, Smilealigners. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Makeo Healthcare Technologies Private Limited (Mumbai, IN). The FDA issued a Cleared decision on February 9, 2023, 100 days after receiving the submission on November 1, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion..
| 510(k) Number | K223338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2022 |
| Decision Date | February 09, 2023 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NXC - Aligner, Sequential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion. |