FDA 510(k)

MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011

K-Number: K051872 · 2005-10-03

Decision Date2005-10-03

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 is the device name listed in this FDA 510(k) record. The listed applicant is Mk-Dent GmbH. It received FDA 510(k) clearance on 2005-10-03 under 510(k) number K051872. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011?

MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 is a medical device that received FDA 510(k) clearance on 2005-10-03. The listed applicant is Mk-Dent GmbH. The 510(k) number is K051872.

When did MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 receive FDA 510(k) clearance?

MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 received FDA 510(k) clearance on 2005-10-03, under 510(k) number K051872.

Who is the listed applicant for MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011?

The FDA 510(k) record lists Mk-Dent GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011?

The FDA product code for MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 is EFB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mk-Dent GmbH as applicant

K032234MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K

Related Devices (Code: EFB)

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI 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.K251389High speed air turbine handpieceFoshan 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.