The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Bifix Hybrid Abutment Cement.
| Device ID | K220640 |
| 510k Number | K220640 |
| Device Name: | Bifix Hybrid Abutment Cement |
| Classification | Cement, Dental |
| Applicant | VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Contact | M. Th. Plaumann |
| Correspondent | T Gerkensmeier VOCO GmbH Anton-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 | 2022-03-04 |
| Decision Date | 2022-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22129951 | K220640 | 000 |
| E22124131 | K220640 | 000 |
| E22124121 | K220640 | 000 |
| E22124111 | K220640 | 000 |
| E22124101 | K220640 | 000 |