FDA 510(k)

Dentium Ti-Base

K号: K171622 · 2018-01-11

决定日期2018-01-11

产品代码NHA

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决定实质等同

器械摘要

Dentium Ti-Base is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K171622. 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 Dentium Ti-Base?

Dentium Ti-Base is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K171622.

When did Dentium Ti-Base receive FDA 510(k) clearance?

Dentium Ti-Base received FDA 510(k) clearance on 2018-01-11, under 510(k) number K171622.

Who is the listed applicant for Dentium Ti-Base?

The FDA 510(k) record lists Dentium Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dentium Ti-Base?

The FDA product code for Dentium Ti-Base is NHA.

列明Dentium Co., Ltd.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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