FDA 510(k) Applications for Medical Device Product Code "EFA"
(Handpiece, Belt And/Or Gear Driven, Dental)

FDA 510(k) Number Applicant Device Name Decision Date
K002709 AMC GENERAL, INC. RACE ENDODONTIC FILE 11/17/2000
K093894 ANTHOGYR ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE 03/03/2010
K040674 ANTHOGYR IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES 06/30/2004
K090676 ANTHOGYR MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES 05/22/2009
K960719 DENTALEZ GROUP STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE 03/28/1996
K960507 DENTALEZ GROUP STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES 03/28/1996
K960260 DENTALEZ GROUP STAR TITAN SERIES MOTORS & ATTACHMENTS 03/28/1996
K971606 DENTSPLY INTL. STERILE FLEXOFILE FILES AND INSTRUMENTS 06/03/1997
K971603 DENTSPLY INTL. STERILE SUREFLEX FILES AND INSTRUMENTS 06/04/1997
K090055 DPM USA CORP. LOW & HIGH SPEED KIT 10/27/2009
K070084 EST. ANTHOGYR MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL 03/08/2007
K061701 J. MORITA USA, INC. HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) 08/25/2006
K953865 J. MORITA USA, INC. SPACELINE FEEL 21 03/20/1996
K143465 Kaltenbach & Voigt Gmbh MASTERmatic LUX 04/09/2015
K163239 Kaltenbach & Voigt GmbH SMARTmatic 03/17/2017
K092446 KALTENBACH & VOIGT GMBH & CO. INTRA LUX HEAD 3 LDSY 11/03/2009
K973062 MEDIDENTA INTL., INC. TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE 10/09/1997
K192809 Micro-NX Co., Ltd. Dental Handpiece 08/25/2020
K220577 Micro-NX Co., Ltd. Dental Handpiece, Model CA160, CA160L, and CA500L 07/29/2022
K013185 NOUVAG AG TCM ENDO III 11/28/2001
K061581 ORTHOSOURCE, INC. EXCEL HIGH SPEED DENTAL HANDPIECE 08/16/2006
K101172 REDENT NOVA LTD RDT3 HANDPIECE HEAD MODEL RDT3 07/27/2010
K092412 SAESHIN PRECISION CO., LTD. STRONG IMPLANT HANDPIECES 09/03/2009
K965238 SIEMENS AG T1 CONTROL HIGH SPEED DENTAL HANDPIECE 03/19/1997


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