The following data is part of a premarket notification filed by Detax Gmbh with the FDA for Freeprint Crown.
| Device ID | K222877 |
| 510k Number | K222877 |
| Device Name: | FREEPRINT Crown |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DETAX GmbH Carl-Zeiss-Strasse 4 Ettlingen, DE D-76275 |
| Contact | Markus Stratmann |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-09-22 |
| Decision Date | 2022-09-23 |