FDA 510(k)

Bio-C Repair Ion+

K号: K201222 · 2021-02-11

申请人Angelus Industria DE Produtos Odontologicos S/A

决定日期2021-02-11

产品代码KIF

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决定实质等同

器械摘要

Bio-C Repair Ion+ is the device name listed in this FDA 510(k) record. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. It received FDA 510(k) clearance on 2021-02-11 under 510(k) number K201222. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bio-C Repair Ion+?

Bio-C Repair Ion+ is a medical device that received FDA 510(k) clearance on 2021-02-11. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. The 510(k) number is K201222.

When did Bio-C Repair Ion+ receive FDA 510(k) clearance?

Bio-C Repair Ion+ received FDA 510(k) clearance on 2021-02-11, under 510(k) number K201222.

Who is the listed applicant for Bio-C Repair Ion+?

The FDA 510(k) record lists Angelus Industria DE Produtos Odontologicos S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bio-C Repair Ion+?

The FDA product code for Bio-C Repair Ion+ is KIF.

列明Angelus Industria DE Produtos Odontologicos S/A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。

K190537BIO-C Sealer Ion+K180199BIO-C TEMP K180185BIO-C修复 K172701BIO-C密封剂

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