GenesisZr UHT700 Zirconia
K-Number: K201608 · 2021-01-28
ApplicantUnited Dental Resources Corporation
Decision Date2021-01-28
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GenesisZr UHT700 Zirconia is a medical device manufactured by United Dental Resources Corporation. It received FDA 510(k) clearance on 2021-01-28 under approval number K201608. 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 UHT700 Zirconia?
GenesisZr UHT700 Zirconia is a medical device that received FDA 510(k) clearance on 2021-01-28. It is manufactured by United Dental Resources Corporation. The 510(k) number is K201608.
When was GenesisZr UHT700 Zirconia approved by the FDA?
GenesisZr UHT700 Zirconia received FDA 510(k) clearance on 2021-01-28, under approval number K201608.
What company makes GenesisZr UHT700 Zirconia?
GenesisZr UHT700 Zirconia is manufactured by United Dental Resources Corporation.
What is the FDA product code for GenesisZr UHT700 Zirconia?
The FDA product code for GenesisZr UHT700 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.