GenesisZr 4Y+ (ST1100) Zirconia
K-Number: K201915 · 2021-02-23
ApplicantUnited Dental Resources Corporation
Decision Date2021-02-23
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GenesisZr 4Y+ (ST1100) Zirconia is a medical device manufactured by United Dental Resources Corporation. It received FDA 510(k) clearance on 2021-02-23 under approval number K201915. 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+ (ST1100) Zirconia?
GenesisZr 4Y+ (ST1100) Zirconia is a medical device that received FDA 510(k) clearance on 2021-02-23. It is manufactured by United Dental Resources Corporation. The 510(k) number is K201915.
When was GenesisZr 4Y+ (ST1100) Zirconia approved by the FDA?
GenesisZr 4Y+ (ST1100) Zirconia received FDA 510(k) clearance on 2021-02-23, under approval number K201915.
What company makes GenesisZr 4Y+ (ST1100) Zirconia?
GenesisZr 4Y+ (ST1100) Zirconia is manufactured by United Dental Resources Corporation.
What is the FDA product code for GenesisZr 4Y+ (ST1100) Zirconia?
The FDA product code for GenesisZr 4Y+ (ST1100) 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.