FDA 510(k)

Concentrix MX-AC 高速手柄

K号: K173465 · 2018-03-28

决定日期2018-03-28

产品代码EFB

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决定实质等同

器械摘要

Concentrix MX-AC High-Speed Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez, Inc.. It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K173465. 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 Concentrix MX-AC High-Speed Handpiece?

Concentrix MX-AC High-Speed Handpiece is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is Dentalez, Inc.. The 510(k) number is K173465.

When did Concentrix MX-AC High-Speed Handpiece receive FDA 510(k) clearance?

Concentrix MX-AC High-Speed Handpiece received FDA 510(k) clearance on 2018-03-28, under 510(k) number K173465.

Who is the listed applicant for Concentrix MX-AC High-Speed Handpiece?

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

What is the FDA product code for Concentrix MX-AC High-Speed Handpiece?

The FDA product code for Concentrix MX-AC High-Speed Handpiece is EFB.

列明Dentalez, 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。

K192412SD500 Elite LubeFree 高速手柄，SD500 Elite 润滑高速手柄，SD500 Pro LubeFree 高速手柄，Pro 润滑高速手柄 K162397泰坦3低速角度附件 K153411430扭矩高速手柄系列 - 430 SWL扭矩高速手柄，430 SW扭矩高速手柄

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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