FDA 510(k)

增材制造义齿树脂

K号: K242884 · 2024-11-22

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

决定日期2024-11-22

产品代码EBI

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决定实质等同

器械摘要

Additively Manufactured Denture Resin 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 2024-11-22 under 510(k) number K242884. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Additively Manufactured Denture Resin?

Additively Manufactured Denture Resin is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K242884.

When did Additively Manufactured Denture Resin receive FDA 510(k) clearance?

Additively Manufactured Denture Resin received FDA 510(k) clearance on 2024-11-22, under 510(k) number K242884.

Who is the listed applicant for Additively Manufactured Denture Resin?

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 Additively Manufactured Denture Resin?

The FDA product code for Additively Manufactured Denture Resin is EBI.

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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