The following data is part of a premarket notification filed by Vertex-dental Bv with the FDA for Nextdent Ortho Flex.
| Device ID | K221022 |
| 510k Number | K221022 |
| Device Name: | NextDent Ortho Flex |
| Classification | Mouthguard, Prescription |
| Applicant | Vertex-Dental BV Centurionbaan 190 Soesterberg, NL 3769AV |
| Contact | Connie Peterse-van Der Koppel |
| Correspondent | Patsy J. Trisler Qserve Group US Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-06 |
| Decision Date | 2022-10-21 |