K210320 is an FDA 510(k) clearance for the ClearCorrect System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Clearcorrect, LLC (Round Rock, US). The FDA issued a Cleared decision on August 6, 2021, 183 days after receiving the submission on February 4, 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 | K210320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2021 |
| Decision Date | August 06, 2021 |
| Days to Decision | 183 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. |