K220140 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 October 5, 2022, 260 days after receiving the submission on January 18, 2022.
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 | K220140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2022 |
| Decision Date | October 05, 2022 |
| Days to Decision | 260 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. |