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510(k) K192809

Device
Dental Handpiece
Applicant
Micro-Nx Co., Ltd.
510(k) number
K192809
Product code
EFA
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-25
Date received
2019-10-01
Regulation
872.4200
Classification name
Handpiece, Belt And/Or Gear Driven, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sojeong Park
Address
22 Maeyeo-Ro 1 Gil, Dong Gu Daegu KR 41059 41059

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EFA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K163239SMARTmaticKaltenbach & Voigt GmbH2017-03-17
K143465MASTERmatic LUXKaltenbach & Voigt GmbH2015-04-09
K101172RDT3 HANDPIECE HEAD MODEL RDT3Redent Nova, Ltd.2010-07-27
K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEAnthogyr2010-03-03
K092446INTRA LUX HEAD 3 LDSYKaltenbach & Voigt GmbH & Co.2009-11-03
K090055LOW & HIGH SPEED KITDpm USA Corp.2009-10-27
K092412STRONG IMPLANT HANDPIECESSaeshin Precision Co., Ltd.2009-09-03
K090676MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLESAnthogyr2009-05-22
K070084MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROLEst. Anthogyr2007-03-08
K061701HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)J. Morita USA, Inc.2006-08-25
K061581EXCEL HIGH SPEED DENTAL HANDPIECEOrthosource, Inc.2006-08-16
K040674IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLESAnthogyr2004-06-30
K013185TCM ENDO IIINOUVAG AG2001-11-28
K002709RACE ENDODONTIC FILEAmc General, Inc.2000-11-17
K973062TWIST RECIPROCATING DISPOSABLE PROPHY ANGLEMedidenta Intl., Inc.1997-10-09