FDA 510(k)

Topzir 牙科氧化锆空白 & 牙科氧化锆预着色空白

K号: K230003 · 2023-03-31

决定日期2023-03-31

产品代码EIH

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Topzir Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K230003. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Topzir Biotech Co., Ltd.. The 510(k) number is K230003.

When did Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank receive FDA 510(k) clearance?

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2023-03-31, under 510(k) number K230003.

Who is the listed applicant for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA 510(k) record lists Topzir Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA product code for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.

官方来源

在 FDA 数据库中查看 →

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。

Topzir 牙科氧化锆空白 & 牙科氧化锆预着色空白

器械摘要

常见问题

相关临床试验

相关器械（代码：EIH）

官方来源