FDA 510(k)

牙槽设计

K号: K200100 · 2020-10-07

决定日期2020-10-07

产品代码PNP

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决定实质等同

器械摘要

Abutment Design is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape A/S. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K200100. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Abutment Design?

Abutment Design is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is 3Shape A/S. The 510(k) number is K200100.

When did Abutment Design receive FDA 510(k) clearance?

Abutment Design received FDA 510(k) clearance on 2020-10-07, under 510(k) number K200100.

Who is the listed applicant for Abutment Design?

The FDA 510(k) record lists 3Shape A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Abutment Design?

The FDA product code for Abutment Design is PNP.

列明3Shape 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。

K1919113Shape Splint Design K180941Ortho System K171634Ortho System K163677Ortho System K161884Ortho System K1514553Shape Abutment Designer Software

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。