FDA 510(k)

Elos 精准® 定制基台

K号: K190299 · 2019-06-26

决定日期2019-06-26

产品代码NHA

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决定实质等同

器械摘要

Elos Accurate® Customized Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2019-06-26 under 510(k) number K190299. 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 Elos Accurate® Customized Abutment?

Elos Accurate® Customized Abutment is a medical device that received FDA 510(k) clearance on 2019-06-26. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K190299.

When did Elos Accurate® Customized Abutment receive FDA 510(k) clearance?

Elos Accurate® Customized Abutment received FDA 510(k) clearance on 2019-06-26, under 510(k) number K190299.

Who is the listed applicant for Elos Accurate® Customized Abutment?

The FDA 510(k) record lists Elos Medtech Pinol A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elos Accurate® Customized Abutment?

The FDA product code for Elos Accurate® Customized Abutment is NHA.

列明Elos Medtech Pinol A/S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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官方来源

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