The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ufi Gel Hard C.
| Device ID | K030916 |
| 510k Number | K030916 |
| Device Name: | UFI GEL HARD C |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-06-19 |