K191823 is an FDA 510(k) clearance for the Clear-Aligners. 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 December 20, 2019, 165 days after receiving the submission on July 8, 2019.
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 | K191823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2019 |
| Decision Date | December 20, 2019 |
| Days to Decision | 165 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. |