The following data is part of a premarket notification filed by United Dental Resources Corporation with the FDA for Genesiszr Uht700 Zirconia.
| Device ID | K201608 |
| 510k Number | K201608 |
| Device Name: | GenesisZr UHT700 Zirconia |
| Classification | Powder, Porcelain |
| Applicant | United Dental Resources Corporation 70 Towncenter Drive University Park, IL 60417 |
| Contact | John Von Thaden |
| Correspondent | John Von Thaden United Dental Resources Corporation 70 Towncenter Drive University Park, IL 60417 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2021-01-28 |