FDA 510(k)

SHOFU Enamel Conditioner

K号: K160086 · 2016-07-21

决定日期2016-07-21

产品代码EBF

咨询委员会DE

决定Substantially Equivalent

器械摘要

SHOFU Enamel Conditioner is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K160086. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SHOFU Enamel Conditioner?

SHOFU Enamel Conditioner is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Shofu Dental Corporation. The 510(k) number is K160086.

When did SHOFU Enamel Conditioner receive FDA 510(k) clearance?

SHOFU Enamel Conditioner received FDA 510(k) clearance on 2016-07-21, under 510(k) number K160086.

Who is the listed applicant for SHOFU Enamel Conditioner?

The FDA 510(k) record lists Shofu Dental Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHOFU Enamel Conditioner?

The FDA product code for SHOFU Enamel Conditioner is EBF.

列明Shofu Dental Corporation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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