FDA 510(k)

TopCEM Vigor SA 自粘树脂粘合剂

K号: K252785 · 2025-12-12

申请人Rizhao Huge Biomaterials Company, Ltd.

决定日期2025-12-12

产品代码EMA

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决定实质等同

器械摘要

TopCEM Vigor SA Self-Adhesive 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 2025-12-12 under 510(k) number K252785. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TopCEM Vigor SA Self-Adhesive Resin Cement?

TopCEM Vigor SA Self-Adhesive Resin Cement is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K252785.

When did TopCEM Vigor SA Self-Adhesive Resin Cement receive FDA 510(k) clearance?

TopCEM Vigor SA Self-Adhesive Resin Cement received FDA 510(k) clearance on 2025-12-12, under 510(k) number K252785.

Who is the listed applicant for TopCEM Vigor SA Self-Adhesive 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 Vigor SA Self-Adhesive Resin Cement?

The FDA product code for TopCEM Vigor SA Self-Adhesive Resin Cement is EMA.

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。

K251271TempFIT 临时牙冠和牙桥树脂 K242530HF-Etchant 氢氟酸蚀刻凝胶 K242572TopCEM-Try 在体试戴凝胶 K242749TopCEM 陶瓷底漆陶瓷耦合剂 K241204TopCEM-贴面光固化贴面水泥 K233082TopCEM 双固化树脂粘合剂

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官方来源

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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。