FDA 510(k)

UF(II) 解剖式基台

K号: K190048 · 2019-09-30

决定日期2019-09-30

产品代码NHA

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决定实质等同

器械摘要

UF(II) Anatomic 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 2019-09-30 under 510(k) number K190048. 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) Anatomic abutment?

UF(II) Anatomic abutment is a medical device that received FDA 510(k) clearance on 2019-09-30. The listed applicant is Dio Corporation. The 510(k) number is K190048.

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

UF(II) Anatomic abutment received FDA 510(k) clearance on 2019-09-30, under 510(k) number K190048.

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

The FDA product code for UF(II) Anatomic 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。

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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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