FDA 510(k)

一次性高速涡轮手机

K号: K172543 · 2018-07-11

申请人Beijing Dongbo Dental Handpiece Co., Ltd.

决定日期2018-07-11

产品代码EFB

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决定实质等同

器械摘要

High-speed Turbine Handpieces for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Dongbo Dental Handpiece Co., Ltd.. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K172543. 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 High-speed Turbine Handpieces for Single Use?

High-speed Turbine Handpieces for Single Use is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Beijing Dongbo Dental Handpiece Co., Ltd.. The 510(k) number is K172543.

When did High-speed Turbine Handpieces for Single Use receive FDA 510(k) clearance?

High-speed Turbine Handpieces for Single Use received FDA 510(k) clearance on 2018-07-11, under 510(k) number K172543.

Who is the listed applicant for High-speed Turbine Handpieces for Single Use?

The FDA 510(k) record lists Beijing Dongbo Dental Handpiece Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High-speed Turbine Handpieces for Single Use?

The FDA product code for High-speed Turbine Handpieces for Single Use is EFB.

列明Beijing Dongbo Dental Handpiece 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。

K202371Highspeed Airturbine Handpiece

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.K251389高速空气涡轮手柄Foshan Topmed Dental 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.K242179Synea 融合手柄（Intensiv & Profin）W&H Dentalwerk Bürmoos GmbH K240337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.

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