FDA 510(k)

BIORES 牙齿种植系统

K号: K252286 · 2026-02-02

申请人Chengdu Besmile Medical Technology Co., Ltd.

决定日期2026-02-02

产品代码DZE

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决定实质等同

器械摘要

BIORES Dental Implant System 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 2026-02-02 under 510(k) number K252286. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BIORES Dental Implant System?

BIORES Dental Implant System is a medical device that received FDA 510(k) clearance on 2026-02-02. The listed applicant is Chengdu Besmile Medical Technology Co., Ltd.. The 510(k) number is K252286.

When did BIORES Dental Implant System receive FDA 510(k) clearance?

BIORES Dental Implant System received FDA 510(k) clearance on 2026-02-02, under 510(k) number K252286.

Who is the listed applicant for BIORES Dental Implant System?

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 BIORES Dental Implant System?

The FDA product code for BIORES Dental Implant System is DZE.

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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