FDA 510(k)

U-对齐器

K号: K191308 · 2020-04-23

申请人Universal Orthodontic Laboratory, Inc.

决定日期2020-04-23

产品代码NXC

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决定实质等同

器械摘要

U-Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Universal Orthodontic Laboratory, Inc.. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K191308. 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 U-Aligner?

U-Aligner is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Universal Orthodontic Laboratory, Inc.. The 510(k) number is K191308.

When did U-Aligner receive FDA 510(k) clearance?

U-Aligner received FDA 510(k) clearance on 2020-04-23, under 510(k) number K191308.

Who is the listed applicant for U-Aligner?

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

What is the FDA product code for U-Aligner?

The FDA product code for U-Aligner is NXC.

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。

U-对齐器

器械摘要

常见问题

相关临床试验

相关器械（代码：NXC）

官方来源