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FDA 510(k)

Ceramill Zolid HT+ 白色

K号: K171876 · 2017-09-20

决定日期2017-09-20
产品代码EIH
咨询委员会DE 请注意,您没有提供具体的医疗设备监管文本内容,因此我无法进行翻译。请提供需要翻译的具体文本,我将根据您的要求进行翻译。
决定实质等同

器械摘要

Ceramill Zolid HT+ white is the device name listed in this FDA 510(k) record. The listed applicant is Amann Girrbach AG. It received FDA 510(k) clearance on 2017-09-20 under 510(k) number K171876. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ceramill Zolid HT+ white?

Ceramill Zolid HT+ white is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Amann Girrbach AG. The 510(k) number is K171876.

When did Ceramill Zolid HT+ white receive FDA 510(k) clearance?

Ceramill Zolid HT+ white received FDA 510(k) clearance on 2017-09-20, under 510(k) number K171876.

Who is the listed applicant for Ceramill Zolid HT+ white?

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

What is the FDA product code for Ceramill Zolid HT+ white?

The FDA product code for Ceramill Zolid HT+ white is EIH.

相关临床试验

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。

列明Amann Girrbach AG为申报人的其他记录

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相关器械(代码:EIH)

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。

官方来源

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