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FDA 510(k)

牙科高速手柄和附件

K号: K173943 · 2018-07-24

申请人Microp Technology (Taiwan), Inc.
决定日期2018-07-24
产品代码EFB
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决定实质等同

器械摘要

Dental High-speed Handpiece and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Microp Technology (Taiwan), Inc.. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K173943. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dental High-speed Handpiece and Accessories?

Dental High-speed Handpiece and Accessories is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Microp Technology (Taiwan), Inc.. The 510(k) number is K173943.

When did Dental High-speed Handpiece and Accessories receive FDA 510(k) clearance?

Dental High-speed Handpiece and Accessories received FDA 510(k) clearance on 2018-07-24, under 510(k) number K173943.

Who is the listed applicant for Dental High-speed Handpiece and Accessories?

The FDA 510(k) record lists Microp Technology (Taiwan), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental High-speed Handpiece and Accessories?

The FDA product code for Dental High-speed Handpiece and Accessories is EFB.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Microp Technology (Taiwan), Inc.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。

K202786牙科低速手机和附件

相关器械（代码：EFB）

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。

K262144DIAMED 手柄；DIAMED 空气电机；DIAMED 空气电机手柄SETAGAYA SEIKI Co., Ltd.K251388牙科气动电机手柄 (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389高速空气涡轮手柄Foshan Topmed Dental Co., Ltd.K242179Synea 融合手柄（Intensiv & Profin）W&H Dentalwerk Bürmoos GmbHK240337牙科手柄（型号：J6-126，J6-136，SH11W2，SH11W3，W401LW，W15LW，W142LW，W11L）Guangdong Jinme Medical Technology Co., Ltd.K241074高速空气涡轮手柄（SCHG01，SCHG03，SCHG18，SCHF19，SCHF22），包括直角和齿轮角度手柄以及空气电机（直角手柄：SCHD05-S，SCHD16-S，SCHD17-S，SCHD24-S，SCHD27-S 齿轮角度手柄：SCHD05-C，SCHD06-C，SCHD16-C，SCHD17-C，SCHD24-C，SCHD27-C，SCHD29-S，SCHB4，SCHB5，SCHB20，SCHB64 空气电机：SCHD16-M，SCHD17-M，SCHD24-M，SCHD27-M）Foshan Soco Precision Instrument Co., Ltd.

官方来源

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