FDA 510(k)

LUXEN CL 牙科液体

K号: K212548 · 2021-12-06

决定日期2021-12-06

产品代码EIH

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决定实质等同

器械摘要

LUXEN CL Dental Liquid is the device name listed in this FDA 510(k) record. The listed applicant is Dentalmax Co., Ltd.. It received FDA 510(k) clearance on 2021-12-06 under 510(k) number K212548. 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 LUXEN CL Dental Liquid?

LUXEN CL Dental Liquid is a medical device that received FDA 510(k) clearance on 2021-12-06. The listed applicant is Dentalmax Co., Ltd.. The 510(k) number is K212548.

When did LUXEN CL Dental Liquid receive FDA 510(k) clearance?

LUXEN CL Dental Liquid received FDA 510(k) clearance on 2021-12-06, under 510(k) number K212548.

Who is the listed applicant for LUXEN CL Dental Liquid?

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

What is the FDA product code for LUXEN CL Dental Liquid?

The FDA product code for LUXEN CL Dental Liquid is EIH.

列明Dentalmax 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。

K241151LUXEN 5G K171585LUXEN Zr, LUXEN Smile

官方来源

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