The following data is part of a premarket notification filed by Dmg Digital Enterprises Se with the FDA for Luxaprint Ortho Plus.
| Device ID | K210940 |
| 510k Number | K210940 |
| Device Name: | LuxaPrint Ortho Plus |
| Classification | Mouthguard, Prescription |
| Applicant | DMG Digital Enterprises SE Elbgaustrasse 248 Hamburg, DE 22547 |
| Contact | Stephan Schafer |
| Correspondent | Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave Ayer, MA 01432 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-09-03 |