The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Bifix Temp.
| Device ID | K143212 |
| 510k Number | K143212 |
| Device Name: | Bifix Temp |
| Classification | Cement, Dental |
| Applicant | VOCO GMBH Anto-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Contact | M. Th. Plaumann |
| Correspondent | T. Gerkensmeier VOCO GMBH Anto-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22110551 | K143212 | 000 |