FDA 510(k)

UF(II) 柱式支架

K号: K193404 · 2020-05-18

决定日期2020-05-18

产品代码NHA

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决定实质等同

器械摘要

UF(II) Bar holder abutment is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2020-05-18 under 510(k) number K193404. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UF(II) Bar holder abutment?

UF(II) Bar holder abutment is a medical device that received FDA 510(k) clearance on 2020-05-18. The listed applicant is Dio Corporation. The 510(k) number is K193404.

When did UF(II) Bar holder abutment receive FDA 510(k) clearance?

UF(II) Bar holder abutment received FDA 510(k) clearance on 2020-05-18, under 510(k) number K193404.

Who is the listed applicant for UF(II) Bar holder abutment?

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

What is the FDA product code for UF(II) Bar holder abutment?

The FDA product code for UF(II) Bar holder abutment is NHA.

列明Dio 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。

K220253Eco Abutment, 多单位基台 K210828DIOnavi-Denture02 K193623DIOnavi-Denture K192263加州大学洛杉矶分校CCM基座 K190048UF(II) 解剖式基台 K181037DIO CAD/CAM 支托

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相关器械（代码：NHA）

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。

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官方来源

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