K192338 is an FDA 510(k) clearance for the NEOLab Clear Aligners. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by New England Ortho Lab, Inc. (Andover, US). The FDA issued a Cleared decision on March 12, 2020, 197 days after receiving the submission on August 28, 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 | K192338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2019 |
| Decision Date | March 12, 2020 |
| Days to Decision | 197 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. |