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EFA — Handpiece, Belt And/Or Gear Driven, Dental Class I

FDA Device Classification

Classification Details

Product Code
EFA
Device Class
Class I
Regulation Number
872.4200
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192809micro-nx coDental HandpieceAugust 25, 2020
K163239kaltenbach and voigtSMARTmaticMarch 17, 2017
K143465kaltenbach and voigtMASTERmatic LUXApril 9, 2015
K101172redent novaRDT3 HANDPIECE HEAD MODEL RDT3July 27, 2010
K093894anthogyrANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEMarch 3, 2010
K092446kaltenbach and voigt gmbh andINTRA LUX HEAD 3 LDSYNovember 3, 2009
K090055dpm usaLOW & HIGH SPEED KITOctober 27, 2009
K092412saeshin precision coSTRONG IMPLANT HANDPIECESSeptember 3, 2009
K090676anthogyrMONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLESMay 22, 2009
K070084est. anthogyrMONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROLMarch 8, 2007
K061701j. morita usaHIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)August 25, 2006
K061581orthosourceEXCEL HIGH SPEED DENTAL HANDPIECEAugust 16, 2006
K040674anthogyrIMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA AJune 30, 2004
K013185nouvagTCM ENDO IIINovember 28, 2001
K002709amc generalRACE ENDODONTIC FILENovember 17, 2000
K973062medidenta intlTWIST RECIPROCATING DISPOSABLE PROPHY ANGLEOctober 9, 1997
K971603dentsply intlSTERILE SUREFLEX FILES AND INSTRUMENTSJune 4, 1997
K971606dentsply intlSTERILE FLEXOFILE FILES AND INSTRUMENTSJune 3, 1997
K965238siemensT1 CONTROL HIGH SPEED DENTAL HANDPIECEMarch 19, 1997
K960719dentalez groupSTAR DENTAL 430 SERIES HIGH SPEED HANDPIECEMarch 28, 1996