FDA 510(k)

牙科高速手柄，牙科低速手柄

K号: K181900 · 2019-12-09

申请人Foshan Cicada Dental Instrument Co, Ltd.

决定日期2019-12-09

产品代码EFB

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决定实质等同

器械摘要

Dental high speed handpiece, Dental low speed handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Cicada Dental Instrument Co, Ltd.. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K181900. 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, Dental low speed handpiece?

Dental high speed handpiece, Dental low speed handpiece is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Foshan Cicada Dental Instrument Co, Ltd.. The 510(k) number is K181900.

When did Dental high speed handpiece, Dental low speed handpiece receive FDA 510(k) clearance?

Dental high speed handpiece, Dental low speed handpiece received FDA 510(k) clearance on 2019-12-09, under 510(k) number K181900.

Who is the listed applicant for Dental high speed handpiece, Dental low speed handpiece?

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

What is the FDA product code for Dental high speed handpiece, Dental low speed handpiece?

The FDA product code for Dental high speed handpiece, Dental low speed handpiece is EFB.

列明Foshan Cicada Dental Instrument 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。

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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 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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