FDA 510(k)

UF(II)窄型植入系统 - 固定装置，UF(II)窄型植入系统 - 上部结构

K号: K161987 · 2017-02-21

决定日期2017-02-21

产品代码DZE

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决定实质等同

器械摘要

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2017-02-21 under 510(k) number K161987. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is a medical device that received FDA 510(k) clearance on 2017-02-21. The listed applicant is Dio Corporation. The 510(k) number is K161987.

When did UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure receive FDA 510(k) clearance?

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure received FDA 510(k) clearance on 2017-02-21, under 510(k) number K161987.

Who is the listed applicant for UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

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) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

The FDA product code for UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is DZE.

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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官方来源

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