FDA 510(k)

Argen 清晰正畸器

K号: K183229 · 2019-06-07

决定日期2019-06-07

产品代码NXC

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决定实质等同

器械摘要

Argen Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Argen Corporation. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K183229. 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 Argen Clear Aligner?

Argen Clear Aligner is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Argen Corporation. The 510(k) number is K183229.

When did Argen Clear Aligner receive FDA 510(k) clearance?

Argen Clear Aligner received FDA 510(k) clearance on 2019-06-07, under 510(k) number K183229.

Who is the listed applicant for Argen Clear Aligner?

The FDA 510(k) record lists Argen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Argen Clear Aligner?

The FDA product code for Argen Clear Aligner is NXC.

列明Argen Corporation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。

K242458ArgenZ MTZ K192846Argen 清晰正畸器，Argen 清晰正畸器高级版 K172430ArgenIS 钛基托 K160248ArgenIS 钛基托

官方来源

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