K241137 is an FDA 510(k) clearance for the Clear Moves Aligner. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Clear Moves Aligners (Lahore, PK). The FDA issued a Cleared decision on August 1, 2024, 99 days after receiving the submission on April 24, 2024.
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 | K241137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2024 |
| Decision Date | August 01, 2024 |
| Days to Decision | 99 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. |