FDA 510(k)

GenesisZr™ 4Y 氧化锆

K号: K182642 · 2019-01-25

决定日期2019-01-25

产品代码EIH

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决定实质等同

器械摘要

GenesisZr™ 4Y 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 2019-01-25 under 510(k) number K182642. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GenesisZr™ 4Y Zirconia?

GenesisZr™ 4Y Zirconia is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is United Dental Resources Corporation. The 510(k) number is K182642.

When did GenesisZr™ 4Y Zirconia receive FDA 510(k) clearance?

GenesisZr™ 4Y Zirconia received FDA 510(k) clearance on 2019-01-25, under 510(k) number K182642.

Who is the listed applicant for GenesisZr™ 4Y 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™ 4Y Zirconia?

The FDA product code for GenesisZr™ 4Y Zirconia is EIH.

列明United Dental Resources Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K201915GenesisZr 4Y+ (ST1100) 氧化锆 K201608GenesisZr UHT700 氧化锆

官方来源

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