FDA 510(k)

牙科氧化锆陶瓷

K号: K250811 · 2025-04-11

申请人Aidite (Qinhuangdao) Technology Co., Ltd.

决定日期2025-04-11

产品代码EIH

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决定实质等同

器械摘要

Dental Zirconia Ceramic is the device name listed in this FDA 510(k) record. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K250811. 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 Zirconia Ceramic?

Dental Zirconia Ceramic is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K250811.

When did Dental Zirconia Ceramic receive FDA 510(k) clearance?

Dental Zirconia Ceramic received FDA 510(k) clearance on 2025-04-11, under 510(k) number K250811.

Who is the listed applicant for Dental Zirconia Ceramic?

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

What is the FDA product code for Dental Zirconia Ceramic?

The FDA product code for Dental Zirconia Ceramic is EIH.

列明Aidite (Qinhuangdao) 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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