FDA 510(k)

BeautiBond Universal

K号: K180803 · 2018-09-26

决定日期2018-09-26

产品代码KLE

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决定实质等同

器械摘要

BeautiBond Universal 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 2018-09-26 under 510(k) number K180803. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BeautiBond Universal?

BeautiBond Universal is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Shofu Dental Corporation. The 510(k) number is K180803.

When did BeautiBond Universal receive FDA 510(k) clearance?

BeautiBond Universal received FDA 510(k) clearance on 2018-09-26, under 510(k) number K180803.

Who is the listed applicant for BeautiBond Universal?

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 BeautiBond Universal?

The FDA product code for BeautiBond Universal is KLE.

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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