K212961 is an FDA 510(k) clearance for the SMILERS. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Biotech Dental Smilers, Sas (Salon De Provence, FR). The FDA issued a Cleared decision on September 20, 2021, 4 days after receiving the submission on September 16, 2021.
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 | K212961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2021 |
| Decision Date | September 20, 2021 |
| Days to Decision | 4 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. |