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 |