FDA 510(k)

TopCEM 双固化树脂粘合剂

K号: K233082 · 2023-12-22

申请人Rizhao Huge Biomaterials Company, Ltd.

决定日期2023-12-22

产品代码EBF

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决定实质等同

器械摘要

TopCEM Dual Cure Resin Cement is the device name listed in this FDA 510(k) record. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K233082. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TopCEM Dual Cure Resin Cement?

TopCEM Dual Cure Resin Cement is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K233082.

When did TopCEM Dual Cure Resin Cement receive FDA 510(k) clearance?

TopCEM Dual Cure Resin Cement received FDA 510(k) clearance on 2023-12-22, under 510(k) number K233082.

Who is the listed applicant for TopCEM Dual Cure Resin Cement?

The FDA 510(k) record lists Rizhao Huge Biomaterials Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TopCEM Dual Cure Resin Cement?

The FDA product code for TopCEM Dual Cure Resin Cement is EBF.

列明Rizhao Huge Biomaterials Company, 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。

K252785TopCEM Vigor SA 自粘树脂粘合剂 K251271TempFIT 临时牙冠和牙桥树脂 K242572TopCEM-Try 在体试戴凝胶 K242530HF-Etchant 氢氟酸蚀刻凝胶 K242749TopCEM 陶瓷底漆陶瓷耦合剂 K241204TopCEM-贴面光固化贴面水泥

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官方来源

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