EKX · Class I · 21 CFR 872.4200

FDA Product Code EKX: Handpiece, Direct Drive, Ac-powered

Leading manufacturers include J. Morita USA, Inc., Guilin Woodpecker Medical Instrument Co., Ltd. and Sirona Dental Systems GmbH.

89
Total
89
Cleared
183d
Avg days
1976
Since
89 devices
25–48 of 89
Cleared Feb 20, 2019
AnyCheck IMT-100
K180953
Dms Co., Ltd.
Dental · 315d
Cleared Oct 11, 2018
LS OIL
K173920
J. Morita USA, Inc.
Dental · 293d
Cleared Aug 20, 2018
Young INFINITY Cordless Handpiece System
K171377
Young Dental Manufacturing Co. 1, LLC
Dental · 467d
Cleared May 16, 2018
IS3
K180527
Hiossen, Inc.
Dental · 77d
Cleared Sep 11, 2017
Tri Auto ZX2
K170275
J. Morita USA, Inc.
Dental · 224d
Cleared Sep 27, 2016
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
K160825
Dentsply Sirona
Dental · 186d
Cleared Sep 12, 2013
IPROPHY MOBILE
K131578
Nakanishi, Inc.
Dental · 104d
Cleared May 04, 2012
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
K112665
J. Morita USA, Inc.
Dental · 234d
Cleared Feb 15, 2012
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
K110278
Nakanishi, Inc.
Dental · 380d
Cleared Jun 06, 2011
MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
K110753
Dentsply International, Inc.
Dental · 80d
Cleared Aug 17, 2007
ROOT ZX II
K071190
J. Morita USA, Inc.
Dental · 109d
Cleared Mar 31, 2006
SIROENDO
K052515
Sirona Dental Systems GmbH
Dental · 198d
Cleared Sep 06, 2005
IMPLANT HANDPIECES
K051661
Sirona Dental Systems GmbH
Dental · 76d
Cleared Aug 21, 2003
DENTAPORT ZX
K031204
J. Morita USA, Inc.
Dental · 127d
Cleared May 26, 1999
QUANTEC-E ENDO SYSTEM
K990739
Sybron Dental Specialties, Inc.
Dental · 82d
Cleared Dec 21, 1998
MODEL MS-1 HANDPIECE
K983413
Parkell, Inc.
Dental · 84d
Cleared Jun 04, 1997
TRI AUTO ZX
K970339
J. Morita USA, Inc.
Dental · 126d
Cleared Jul 01, 1993
FRESENIUS PD+ EXCHANGE DEVICE
K915634
Fresenius USA, Inc.
Dental · 562d
Cleared Jun 23, 1987
PERIOTEST
K872171
Siemens Medical Solutions USA, Inc.
Dental · 15d
Cleared Nov 23, 1976
PERITONEAL DIALYSIS SYSTEM
K760724
Physio-Control Corp.
Dental · 57d