K173738 is an FDA 510(k) clearance for the Archworx. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Utah Medical Products and Services (Murray, US). The FDA issued a Cleared decision on February 26, 2021, 1178 days after receiving the submission on December 6, 2017.
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 | K173738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2017 |
| Decision Date | February 26, 2021 |
| Days to Decision | 1178 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. |