The following data is part of a premarket notification filed by United Dental Resources Corporation with the FDA for Genesiszr™ 4y Zirconia.
| Device ID | K182642 |
| 510k Number | K182642 |
| Device Name: | GenesisZr™ 4Y Zirconia |
| Classification | Powder, Porcelain |
| Applicant | United Dental Resources Corporation 70 Towncenter Drive University Park, IL 60484 |
| Contact | John Von Thaden |
| Correspondent | John Von Thaden United Dental Resources Corporation 70 Towncenter Drive University Park, IL 60484 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-01-25 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GENESISZR 88011053 5741641 Live/Registered |
Crittenden, Keith 2018-06-22 |