FDA 510(k)

Vsmilehappyzir 齿科氧化锆空白 & 齿科氧化锆预着色空白

K号: K221242 · 2022-07-29

决定日期2022-07-29

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

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vsmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K221242. 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 Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Hunan Vsmile Biotechnology Co., Ltd.. The 510(k) number is K221242.

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

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2022-07-29, under 510(k) number K221242.

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

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

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

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

列明Hunan Vsmile Biotechnology Co., Ltd.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。

K242407牙科玻璃陶瓷块（HT，LT，MT）

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。