FDA 510(k)

Invisalign® 系统带下颌前移功能及咬合块

K号: K232233 · 2023-09-26

决定日期2023-09-26

产品代码NXC

咨询委员会DE

决定Substantially Equivalent

器械摘要

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K232233. 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 Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is Align Technology, Inc.. The 510(k) number is K232233.

When did Invisalign System with Mandibular Advancement Featuring Occlusal Blocks receive FDA 510(k) clearance?

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks received FDA 510(k) clearance on 2023-09-26, under 510(k) number K232233.

Who is the listed applicant for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

The FDA 510(k) record lists Align Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

The FDA product code for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is NXC.

列明Align Technology, Inc.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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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。