FDA 510(k)

釉质涂层树脂

K号: K230455 · 2023-07-25

申请人Rizhao Huge Biomaterials Company, Ltd.

决定日期2023-07-25

产品代码EBC

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

Enamel Coating Resin 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 2023-07-25 under 510(k) number K230455. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Enamel Coating Resin?

Enamel Coating Resin is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K230455.

When did Enamel Coating Resin receive FDA 510(k) clearance?

Enamel Coating Resin received FDA 510(k) clearance on 2023-07-25, under 510(k) number K230455.

Who is the listed applicant for Enamel Coating Resin?

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 Enamel Coating Resin?

The FDA product code for Enamel Coating Resin is EBC.

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

查看所有 13 个设备 →

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。