FDA 510(k)

FACE4D矫正器

K号: K260527 · 2026-07-02

决定日期2026-07-02

产品代码NXC

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决定实质等同

器械摘要

FACE4D Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Avinent Implant System S.L.U.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K260527. 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 FACE4D Aligner?

FACE4D Aligner is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Avinent Implant System S.L.U.. The 510(k) number is K260527.

When did FACE4D Aligner receive FDA 510(k) clearance?

FACE4D Aligner received FDA 510(k) clearance on 2026-07-02, under 510(k) number K260527.

Who is the listed applicant for FACE4D Aligner?

The FDA 510(k) record lists Avinent Implant System S.L.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACE4D Aligner?

The FDA product code for FACE4D Aligner is NXC.

列明Avinent Implant System S.L.U.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。

K201533Avinent 生物模拟珊瑚和海洋冰山灭菌盒 K191566Avinent 手术托盘

官方来源

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