The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ufi Gel Hard.
| Device ID | K993827 |
| 510k Number | K993827 |
| Device Name: | UFI GEL HARD |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | VOCO GMBH 4235 BEACONSFIELD Montreal, CA Qc,h4a 2h4 |
| Contact | Shuojia Dong |
| Correspondent | Shuojia Dong VOCO GMBH 4235 BEACONSFIELD Montreal, CA Qc,h4a 2h4 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-12 |
| Decision Date | 2000-01-20 |