The following data is part of a premarket notification filed by Detax Gmbh & Co.kg with the FDA for Freeprint Temp.
| Device ID | K200273 |
| 510k Number | K200273 |
| Device Name: | FREEPRINT Temp |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2020-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850026127058 | K200273 | 000 |
| 00850026127041 | K200273 | 000 |
| 00850026127034 | K200273 | 000 |
| 00850026127027 | K200273 | 000 |
| 00850026127010 | K200273 | 000 |
| 00850026127003 | K200273 | 000 |