K193130 is an FDA 510(k) clearance for the MVP Aligner System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Mvp Aligners, LLC (New York, US). The FDA issued a Cleared decision on August 7, 2020, 269 days after receiving the submission on November 12, 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 | K193130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2019 |
| Decision Date | August 07, 2020 |
| Days to Decision | 269 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. |