FDA 510(k)

Carriere® Motion Pro® Clear Bite Corrector

K号: K252760 · 2025-11-27

决定日期2025-11-27

产品代码DYW

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决定实质等同

器械摘要

Carriere® Motion Pro® Clear Bite Corrector is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Organizers, Inc.. It received FDA 510(k) clearance on 2025-11-27 under 510(k) number K252760. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Carriere® Motion Pro® Clear Bite Corrector?

Carriere® Motion Pro® Clear Bite Corrector is a medical device that received FDA 510(k) clearance on 2025-11-27. The listed applicant is Ortho Organizers, Inc.. The 510(k) number is K252760.

When did Carriere® Motion Pro® Clear Bite Corrector receive FDA 510(k) clearance?

Carriere® Motion Pro® Clear Bite Corrector received FDA 510(k) clearance on 2025-11-27, under 510(k) number K252760.

Who is the listed applicant for Carriere® Motion Pro® Clear Bite Corrector?

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

What is the FDA product code for Carriere® Motion Pro® Clear Bite Corrector?

The FDA product code for Carriere® Motion Pro® Clear Bite Corrector is DYW.

列明Ortho Organizers, 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。

K173440Carriere SLX 3D Clear K160720Carriere Motion Clear Class II

官方来源

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