K213026 is an FDA 510(k) clearance for the Clear Aligner. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Shenzhen Meiming Dentistry Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 16, 2022, 329 days after receiving the submission on September 21, 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 | K213026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2021 |
| Decision Date | August 16, 2022 |
| Days to Decision | 329 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. |