FDA 510(k)

定制基台和螺钉

K号: K242768 · 2025-09-02

申请人Chengdu Besmile Medical Technology Co., Ltd.

决定日期2025-09-02

产品代码NHA

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决定实质等同

器械摘要

Customized Abutment and Screw 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 2025-09-02 under 510(k) number K242768. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Customized Abutment and Screw?

Customized Abutment and Screw is a medical device that received FDA 510(k) clearance on 2025-09-02. The listed applicant is Chengdu Besmile Medical Technology Co., Ltd.. The 510(k) number is K242768.

When did Customized Abutment and Screw receive FDA 510(k) clearance?

Customized Abutment and Screw received FDA 510(k) clearance on 2025-09-02, under 510(k) number K242768.

Who is the listed applicant for Customized Abutment and Screw?

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 Customized Abutment and Screw?

The FDA product code for Customized Abutment and Screw is NHA.

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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相关器械（代码：NHA）

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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