FDA 510(k)

氧化锆牙科陶瓷

K号: K214005 · 2022-02-18

申请人Shenzhen Yurucheng Dental Materials Co., Ltd.

决定日期2022-02-18

产品代码EIH

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决定实质等同

器械摘要

Zirconia Dental Ceramics is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yurucheng Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K214005. 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 Dental Ceramics?

Zirconia Dental Ceramics is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Shenzhen Yurucheng Dental Materials Co., Ltd.. The 510(k) number is K214005.

When did Zirconia Dental Ceramics receive FDA 510(k) clearance?

Zirconia Dental Ceramics received FDA 510(k) clearance on 2022-02-18, under 510(k) number K214005.

Who is the listed applicant for Zirconia Dental Ceramics?

The FDA 510(k) record lists Shenzhen Yurucheng Dental Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zirconia Dental Ceramics?

The FDA product code for Zirconia Dental Ceramics is EIH.

列明Shenzhen Yurucheng Dental Materials 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。

K233016牙科玻璃陶瓷 K214003牙科氧化锆预着色块

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