FDA 510(k)

Bifix 牙贴面 LC，Bifix 牙贴面试装

K号: K252606 · 2026-03-20

决定日期2026-03-20

产品代码EMA

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

Bifix Veneer LC, Bifix Veneer Try-In is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K252606. 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 Bifix Veneer LC, Bifix Veneer Try-In?

Bifix Veneer LC, Bifix Veneer Try-In is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Voco GmbH. The 510(k) number is K252606.

When did Bifix Veneer LC, Bifix Veneer Try-In receive FDA 510(k) clearance?

Bifix Veneer LC, Bifix Veneer Try-In received FDA 510(k) clearance on 2026-03-20, under 510(k) number K252606.

Who is the listed applicant for Bifix Veneer LC, Bifix Veneer Try-In?

The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bifix Veneer LC, Bifix Veneer Try-In?

The FDA product code for Bifix Veneer LC, Bifix Veneer Try-In is EMA.

列明Voco GmbH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。

K252073VOCO Profluorid 漱口水 + BioMin K261357Grandio disc 多色 K251390MTA vpt K251239GrandioSO 无限 K231817AlignerFlow LC K231591V-Print c&b 温度

查看所有 29 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。