FDA 510(k)

BeautiLink SA

K号: K233161 · 2023-09-28

决定日期2023-09-28

产品代码EMA

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决定实质等同

器械摘要

BeautiLink SA 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 2023-09-28 under 510(k) number K233161. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BeautiLink SA?

BeautiLink SA is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Shofu Dental Corporation. The 510(k) number is K233161.

When did BeautiLink SA receive FDA 510(k) clearance?

BeautiLink SA received FDA 510(k) clearance on 2023-09-28, under 510(k) number K233161.

Who is the listed applicant for BeautiLink SA?

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 BeautiLink SA?

The FDA product code for BeautiLink SA is EMA.

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。

K252808GlasIonomer FX-LC K252165ZIRCONOMER P K251470ResiCem EX K251578BEAUTIFIL II K222253GlasIonomer FX ULTRA K212939复古_prime_压印机

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