FDA 510(k)

牙科高速涡轮手柄

K号: K170229 · 2017-11-08

申请人Guangdong Jinme Medical Technology Co., Ltd.

决定日期2017-11-08

产品代码EFB

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决定实质等同

器械摘要

Dental High-speed Turbine Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-11-08 under 510(k) number K170229. 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 Turbine Handpiece?

Dental High-speed Turbine Handpiece is a medical device that received FDA 510(k) clearance on 2017-11-08. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. The 510(k) number is K170229.

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

Dental High-speed Turbine Handpiece received FDA 510(k) clearance on 2017-11-08, under 510(k) number K170229.

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

The FDA 510(k) record lists Guangdong Jinme Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

列明Guangdong Jinme Medical Technology 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。

K240337牙科手柄（型号：J6-126，J6-136，SH11W2，SH11W3，W401LW，W15LW，W142LW，W11L）K240340Surgical Drive System (型号：ES70，ES90，E8)K170236牙科低速涡轮手机

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.

官方来源

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