The following data is part of a premarket notification filed by Mvp Aligners, Llc with the FDA for Mvp Aligner System.
| Device ID | K193130 |
| 510k Number | K193130 |
| Device Name: | MVP Aligner System |
| Classification | Aligner, Sequential |
| Applicant | MVP Aligners, LLC 5-9 Union Square West New York, NY 10003 |
| Contact | Daniel Michaeli |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2020-08-07 |