FDA 510(k)

Bio-TackS 正畸迷你植入物

K号: K190871 · 2020-01-17

决定日期2020-01-17

产品代码OAT

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决定实质等同

器械摘要

Bio-TackS Orthodontic Mini Implant is the device name listed in this FDA 510(k) record. The listed applicant is Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K190871. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bio-TackS Orthodontic Mini Implant?

Bio-TackS Orthodontic Mini Implant is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Biocetec Co., Ltd.. The 510(k) number is K190871.

When did Bio-TackS Orthodontic Mini Implant receive FDA 510(k) clearance?

Bio-TackS Orthodontic Mini Implant received FDA 510(k) clearance on 2020-01-17, under 510(k) number K190871.

Who is the listed applicant for Bio-TackS Orthodontic Mini Implant?

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

What is the FDA product code for Bio-TackS Orthodontic Mini Implant?

The FDA product code for Bio-TackS Orthodontic Mini Implant is OAT.

列明Biocetec 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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