K210373 is an FDA 510(k) clearance for the Clear Aligners. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Shenzhen Yinuo Dental Technology Co.Ltd (Shenzhen, CN). The FDA issued a Cleared decision on August 27, 2021, 200 days after receiving the submission on February 8, 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 | K210373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2021 |
| Decision Date | August 27, 2021 |
| Days to Decision | 200 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. |