FDA 510(k)

DIOnavi-Denture02

K号: K210828 · 2021-03-23

决定日期2021-03-23

产品代码EBI

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决定实质等同

器械摘要

DIOnavi-Denture02 is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2021-03-23 under 510(k) number K210828. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DIOnavi-Denture02?

DIOnavi-Denture02 is a medical device that received FDA 510(k) clearance on 2021-03-23. The listed applicant is Dio Corporation. The 510(k) number is K210828.

When did DIOnavi-Denture02 receive FDA 510(k) clearance?

DIOnavi-Denture02 received FDA 510(k) clearance on 2021-03-23, under 510(k) number K210828.

Who is the listed applicant for DIOnavi-Denture02?

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 DIOnavi-Denture02?

The FDA product code for DIOnavi-Denture02 is EBI.

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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