The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ufi Gel Hard C.
| Device ID | K143486 |
| 510k Number | K143486 |
| Device Name: | Ufi Gel Hard C |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | VOCO GMBH ANTON-FLETTNER-STR 1-3 Cuxhaven, DE D-27472 |
| Contact | M.th. Plaumann |
| Correspondent | Dr.t. Gerkensmeier VOCO GMBH ANTON-FLETTNER-STR 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-08 |
| Decision Date | 2015-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620704513282 | K143486 | 000 |
| D66207045130226 | K143486 | 000 |
| D6620704512942 | K143486 | 000 |