GenesisZr 4Y+ (ST1100) 氧化锆
K号: K201915 · 2021-02-23
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决定日期2021-02-23
产品代码EIH
咨询委员会DE
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决定实质等同
器械摘要
GenesisZr 4Y+ (ST1100) 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 2021-02-23 under 510(k) number K201915. 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+ (ST1100) Zirconia?
GenesisZr 4Y+ (ST1100) Zirconia is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is United Dental Resources Corporation. The 510(k) number is K201915.
When did GenesisZr 4Y+ (ST1100) Zirconia receive FDA 510(k) clearance?
GenesisZr 4Y+ (ST1100) Zirconia received FDA 510(k) clearance on 2021-02-23, under 510(k) number K201915.
Who is the listed applicant for GenesisZr 4Y+ (ST1100) 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+ (ST1100) Zirconia?
The FDA product code for GenesisZr 4Y+ (ST1100) Zirconia is EIH.
相关临床试验
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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。
相关器械（代码：EIH）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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