The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Bifix Dental Cement.
| Device ID | K926458 |
| 510k Number | K926458 |
| Device Name: | BIFIX DENTAL CEMENT |
| Classification | Cement, Dental |
| Applicant | VOCO GMBH 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan G Dick |
| Correspondent | Evan G Dick VOCO GMBH 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-24 |
| Decision Date | 1993-03-31 |