K241187 is an FDA 510(k) clearance for the Alien Aligners. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Alien Milling Technologies (Glendora, US). The FDA issued a Cleared decision on July 26, 2024, 88 days after receiving the submission on April 29, 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 | K241187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2024 |
| Decision Date | July 26, 2024 |
| Days to Decision | 88 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. |