The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Bifix Se.
| Device ID | K083438 |
| 510k Number | K083438 |
| Device Name: | BIFIX SE |
| Classification | Cement, Dental |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Th. Plaumann |
| Correspondent | Th. Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-20 |
| Decision Date | 2009-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D66207111063405 | K083438 | 000 |