FDA 510(k)

牙科手柄，无线根管治疗手柄，endoit

K号: K232810 · 2023-11-09

决定日期2023-11-09

产品代码EKX

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决定实质等同

器械摘要

Dental Handpiece, Wireless Endodontic Handpiece, endoit is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K232810. 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 Dental Handpiece, Wireless Endodontic Handpiece, endoit?

Dental Handpiece, Wireless Endodontic Handpiece, endoit is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K232810.

When did Dental Handpiece, Wireless Endodontic Handpiece, endoit receive FDA 510(k) clearance?

Dental Handpiece, Wireless Endodontic Handpiece, endoit received FDA 510(k) clearance on 2023-11-09, under 510(k) number K232810.

Who is the listed applicant for Dental Handpiece, Wireless Endodontic Handpiece, endoit?

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

What is the FDA product code for Dental Handpiece, Wireless Endodontic Handpiece, endoit?

The FDA product code for Dental Handpiece, Wireless Endodontic Handpiece, endoit is EKX.

列明Micro-Nx 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。

K231562ELEC 发动机（型号：ISE-170L）K220577牙科手柄，型号CA160，CA160L，和CA500L K201191ELEC-LED K201192Impla-NX（型号：ISE-270M）K192809牙科手柄 K161500MEG-TORQ

查看所有 7 个设备 →

官方来源

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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。