K220835 is an FDA 510(k) clearance for the Arkligners. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Arklign Laboratories (San Jose, US). The FDA issued a Cleared decision on August 12, 2022, 143 days after receiving the submission on March 22, 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 | K220835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2022 |
| Decision Date | August 12, 2022 |
| Days to Decision | 143 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. |