FDA 510(k)

BeautiCem Veneer Kit

K号: K180649 · 2018-06-11

决定日期2018-06-11

产品代码EBF

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决定实质等同

器械摘要

BeautiCem Veneer Kit 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 2018-06-11 under 510(k) number K180649. 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 BeautiCem Veneer Kit?

BeautiCem Veneer Kit is a medical device that received FDA 510(k) clearance on 2018-06-11. The listed applicant is Shofu Dental Corporation. The 510(k) number is K180649.

When did BeautiCem Veneer Kit receive FDA 510(k) clearance?

BeautiCem Veneer Kit received FDA 510(k) clearance on 2018-06-11, under 510(k) number K180649.

Who is the listed applicant for BeautiCem Veneer Kit?

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 BeautiCem Veneer Kit?

The FDA product code for BeautiCem Veneer Kit 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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