FDA 510(k)

uLab Systems 牙齿矫正器套装

K号: K211510 · 2022-02-24

决定日期2022-02-24

产品代码NXC

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决定实质等同

器械摘要

uLab Systems Dental Aligner Kit is the device name listed in this FDA 510(k) record. The listed applicant is Ulab Systems, Inc.. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K211510. 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 uLab Systems Dental Aligner Kit?

uLab Systems Dental Aligner Kit is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Ulab Systems, Inc.. The 510(k) number is K211510.

When did uLab Systems Dental Aligner Kit receive FDA 510(k) clearance?

uLab Systems Dental Aligner Kit received FDA 510(k) clearance on 2022-02-24, under 510(k) number K211510.

Who is the listed applicant for uLab Systems Dental Aligner Kit?

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

What is the FDA product code for uLab Systems Dental Aligner Kit?

The FDA product code for uLab Systems Dental Aligner Kit is NXC.

列明Ulab Systems, 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。

K200772ULab Systems uDesign 软件 K192596ULab Systems 牙齿矫正器套装 K171295ULab Systems治疗方案软件

官方来源

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