K210613 is an FDA 510(k) clearance for the HIT Clear Aligner. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Cdb Corporation (Leland, US). The FDA issued a Cleared decision on June 4, 2021, 95 days after receiving the submission on March 1, 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 | K210613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2021 |
| Decision Date | June 04, 2021 |
| Days to Decision | 95 days |
| Submission Type | Special |
| 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. |