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FDA 510(k)

WOlf 高速手机 - 中头，WOlf 高速手机 - 小头

K号: K160410 · 2016-09-29

申请人Dental Savings Club
决定日期2016-09-29
产品代码EFB
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决定实质等同

器械摘要

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is the device name listed in this FDA 510(k) record. The listed applicant is Dental Savings Club. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K160410. 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 WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Dental Savings Club. The 510(k) number is K160410.

When did WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head receive FDA 510(k) clearance?

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head received FDA 510(k) clearance on 2016-09-29, under 510(k) number K160410.

Who is the listed applicant for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

The FDA 510(k) record lists Dental Savings Club as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

The FDA product code for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is EFB.

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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 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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