K210763 is an FDA 510(k) clearance for the Inman Digital Clear Aligners. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Inman Orthodontic Laboratories, Inc. (Coral Springs, US). The FDA issued a Cleared decision on September 29, 2021, 198 days after receiving the submission on March 15, 2021.
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 | K210763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2021 |
| Decision Date | September 29, 2021 |
| Days to Decision | 198 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. |