FDA 510(k)

增材制造矫治器树脂

K号: K251415 · 2025-08-27

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

决定日期2025-08-27

产品代码NXC

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决定实质等同

器械摘要

Additively Manufactured Aligner 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 2025-08-27 under 510(k) number K251415. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Additively Manufactured Aligner Resin?

Additively Manufactured Aligner Resin is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K251415.

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

Additively Manufactured Aligner Resin received FDA 510(k) clearance on 2025-08-27, under 510(k) number K251415.

Who is the listed applicant for Additively Manufactured Aligner 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 Aligner Resin?

The FDA product code for Additively Manufactured Aligner Resin is NXC.

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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