FDA 510(k)

RODIN钛3D树脂

K号: K240688 · 2024-06-20

决定日期2024-06-20

产品代码EBI

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

RODIN Titan 3D Resin is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K240688. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RODIN Titan 3D Resin?

RODIN Titan 3D Resin is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K240688.

When did RODIN Titan 3D Resin receive FDA 510(k) clearance?

RODIN Titan 3D Resin received FDA 510(k) clearance on 2024-06-20, under 510(k) number K240688.

Who is the listed applicant for RODIN Titan 3D Resin?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RODIN Titan 3D Resin?

The FDA product code for RODIN Titan 3D Resin is EBI.

列明Belport Company, Inc., Gingi-Pak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。

K260430瓷器刻蚀凝胶 K251775RODIN水泥 K250279RC-SwiftPrep K250222SDF Pro K231060ProMin牙科脱敏凝胶 K231793RODIN 3D树脂夹板，硬/软

查看所有 11 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。