K232074 is an FDA 510(k) clearance for the Serafin®. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Tns Co., Ltd. (Geumcheon-Gu, KR). The FDA issued a Cleared decision on February 22, 2024, 225 days after receiving the submission on July 12, 2023.
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 | K232074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2023 |
| Decision Date | February 22, 2024 |
| Days to Decision | 225 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. |