FDA 510(k)

PROXEO Twist 无线抛光系统 PL-40 H

K号: K201703 · 2021-02-24

决定日期2021-02-24

产品代码EKX

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

PROXEO Twist Cordless Polishing System PL-40 H is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K201703. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PROXEO Twist Cordless Polishing System PL-40 H?

PROXEO Twist Cordless Polishing System PL-40 H is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K201703.

When did PROXEO Twist Cordless Polishing System PL-40 H receive FDA 510(k) clearance?

PROXEO Twist Cordless Polishing System PL-40 H received FDA 510(k) clearance on 2021-02-24, under 510(k) number K201703.

Who is the listed applicant for PROXEO Twist Cordless Polishing System PL-40 H?

The FDA 510(k) record lists W&H Dentalwerk Buermoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROXEO Twist Cordless Polishing System PL-40 H?

The FDA product code for PROXEO Twist Cordless Polishing System PL-40 H is EKX.

列明W&H Dentalwerk Buermoos 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。

K253776Implantmed Plus II & Piezomed Plus II 模块 K243280Piezomed Pro（Piezomed Pro 模块 M-PM100 包括手柄 M-PH350，Piezomed Pro 工具（各种尖端）和附件）K181858电动手持电机 K171553W&H Assistina 双胞胎

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。