FDA 510(k)

BIO-C密封剂

K号: K172701 · 2018-01-04

申请人Angelus Industria DE Produtos Odontologicos S/A

决定日期2018-01-04

产品代码KIF

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决定实质等同

器械摘要

BIO-C SEALER 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 2018-01-04 under 510(k) number K172701. 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 SEALER?

BIO-C SEALER is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. The 510(k) number is K172701.

When did BIO-C SEALER receive FDA 510(k) clearance?

BIO-C SEALER received FDA 510(k) clearance on 2018-01-04, under 510(k) number K172701.

Who is the listed applicant for BIO-C SEALER?

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 SEALER?

The FDA product code for BIO-C SEALER 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。

K201222Bio-C Repair Ion+K190537BIO-C Sealer Ion+K180199BIO-C TEMP K180185BIO-C修复

官方来源

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