FDA 510(k)

Concentrix MX-AC High-Speed Handpiece

K-번호: K173465 · 2018-03-28

결정일2018-03-28

제품 코드EFB

자문 위원회DE

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Dentalez, Inc.를 신청인으로 등재한 기타 기록

K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece K162397Titan 3 Low Speed Angle Attachments K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece

관련 기기 (코드: EFB)

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K251388Dental air-motor handpiece (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 Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbH K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.

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