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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is United Dental Resources Corporation. It received FDA 510(k) clearance on 2021-01-28 under 510(k) 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. The listed applicant is United Dental Resources Corporation. The 510(k) number is K201608.

When did GenesisZr UHT700 Zirconia receive FDA 510(k) clearance?

GenesisZr UHT700 Zirconia received FDA 510(k) clearance on 2021-01-28, under 510(k) number K201608.

Who is the listed applicant for GenesisZr UHT700 Zirconia?

The FDA 510(k) record lists United Dental Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GenesisZr UHT700 Zirconia?

The FDA product code for GenesisZr UHT700 Zirconia is EIH.

Other records listing United Dental Resources Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201915GenesisZr 4Y+ (ST1100) ZirconiaK182642GenesisZr™ 4Y Zirconia

Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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.

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