The following data is part of a premarket notification filed by Detax Gmbh & Co. Kg with the FDA for Freeprint Denture.
| Device ID | K200461 |
| 510k Number | K200461 |
| Device Name: | Freeprint Denture |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Detax GmbH & Co. KG Carl-Zeiss-Strasse 4 Ettlingen, DE 76275 |
| Contact | Markus Stratmann |
| Correspondent | Jan-paul Van Loon Qserve Consultancy BV. Utrechtseweg 310 - Bldg B42 Arnhem, NL 6812 Ar |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-25 |
| Decision Date | 2020-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850026127072 | K200461 | 000 |