FDA 510(k)

氧化锆块

K号: K222520 · 2022-11-14

申请人Yilink (Tianjin) Biotechnology Co., Ltd.

决定日期2022-11-14

产品代码EIH

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决定实质等同

器械摘要

Zirconia Block is the device name listed in this FDA 510(k) record. The listed applicant is Yilink (Tianjin) Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-14 under 510(k) number K222520. 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 Zirconia Block?

Zirconia Block is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Yilink (Tianjin) Biotechnology Co., Ltd.. The 510(k) number is K222520.

When did Zirconia Block receive FDA 510(k) clearance?

Zirconia Block received FDA 510(k) clearance on 2022-11-14, under 510(k) number K222520.

Who is the listed applicant for Zirconia Block?

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

What is the FDA product code for Zirconia Block?

The FDA product code for Zirconia Block is EIH.

列明Yilink (Tianjin) 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。

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