FDA 510(k)

牙齿着色树脂材料

K号: K162323 · 2017-01-12

决定日期2017-01-12

产品代码EBF

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

Tooth Shade Resin Material is the device name listed in this FDA 510(k) record. The listed applicant is Liaoning Upcera Co., Ltd.. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K162323. 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 Tooth Shade Resin Material?

Tooth Shade Resin Material is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Liaoning Upcera Co., Ltd.. The 510(k) number is K162323.

When did Tooth Shade Resin Material receive FDA 510(k) clearance?

Tooth Shade Resin Material received FDA 510(k) clearance on 2017-01-12, under 510(k) number K162323.

Who is the listed applicant for Tooth Shade Resin Material?

The FDA 510(k) record lists Liaoning Upcera Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tooth Shade Resin Material?

The FDA product code for Tooth Shade Resin Material is EBF.

列明Liaoning Upcera 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。

K253380“FLNT 基础”和“FLNT 临时”K253973Gradual 钛酸锆牙冠空白 - GT(F) P1，GT(F) P2 和 SP 系列 K240153陶瓷蚀刻剂（HF-5 和 HF-9）K231687Gradual 钛酸锆牙冠空白 K181167Upcera 釉料膏，釉料粉，和釉料液体

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。