The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Voco Ionofil Molar Ac Quick.
| Device ID | K102612 |
| 510k Number | K102612 |
| Device Name: | VOCO IONOFIL MOLAR AC QUICK |
| Classification | Cement, Dental |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | T Gerkensmeier |
| Correspondent | T Gerkensmeier 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 | 2010-09-10 |
| Decision Date | 2010-11-19 |