FDA 510(k)

ARENA Star，Galaxy Star

K号: K250063 · 2025-07-10

决定日期2025-07-10

产品代码EIH

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决定实质等同

器械摘要

ARENA Star, Galaxy Star is the device name listed in this FDA 510(k) record. The listed applicant is Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2025-07-10 under 510(k) number K250063. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARENA Star, Galaxy Star?

ARENA Star, Galaxy Star is a medical device that received FDA 510(k) clearance on 2025-07-10. The listed applicant is Arum Dentistry Co., Ltd.. The 510(k) number is K250063.

When did ARENA Star, Galaxy Star receive FDA 510(k) clearance?

ARENA Star, Galaxy Star received FDA 510(k) clearance on 2025-07-10, under 510(k) number K250063.

Who is the listed applicant for ARENA Star, Galaxy Star?

The FDA 510(k) record lists Arum Dentistry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARENA Star, Galaxy Star?

The FDA product code for ARENA Star, Galaxy Star is EIH.

列明Arum Dentistry Co., Ltd.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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