GenesisZr 4Y Zirconia
K-Number: K182642 · 2019-01-25
ApplicantUnited Dental Resources Corporation
Decision Date2019-01-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GenesisZr 4Y Zirconia is a medical device manufactured by United Dental Resources Corporation. It received FDA 510(k) clearance on 2019-01-25 under approval number K182642. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GenesisZr 4Y Zirconia?
GenesisZr 4Y Zirconia is a medical device that received FDA 510(k) clearance on 2019-01-25. It is manufactured by United Dental Resources Corporation. The 510(k) number is K182642.
When was GenesisZr 4Y Zirconia approved by the FDA?
GenesisZr 4Y Zirconia received FDA 510(k) clearance on 2019-01-25, under approval number K182642.
What company makes GenesisZr 4Y Zirconia?
GenesisZr 4Y Zirconia is manufactured by United Dental Resources Corporation.
What is the FDA product code for GenesisZr 4Y Zirconia?
The FDA product code for GenesisZr 4Y Zirconia is EIH.
Other Devices by United Dental Resources Corporation
Related Devices (Code: EIH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.