FDA 510(k)

牙科玻璃陶瓷

K号: K232673 · 2024-01-23

申请人Chengdu Besmile Medical Technology Co., Ltd.

决定日期2024-01-23

产品代码EIH

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决定实质等同

器械摘要

Dental Glass Ceramics is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Besmile Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-23 under 510(k) number K232673. 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 Dental Glass Ceramics?

Dental Glass Ceramics is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Chengdu Besmile Medical Technology Co., Ltd.. The 510(k) number is K232673.

When did Dental Glass Ceramics receive FDA 510(k) clearance?

Dental Glass Ceramics received FDA 510(k) clearance on 2024-01-23, under 510(k) number K232673.

Who is the listed applicant for Dental Glass Ceramics?

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

What is the FDA product code for Dental Glass Ceramics?

The FDA product code for Dental Glass Ceramics is EIH.

列明Chengdu Besmile Medical Technology 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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