EKX · Class I · 21 CFR 872.4200

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

Leading manufacturers include J. Morita USA, Inc., Aseptico, Inc. and W&H Dentalwerk Buermoos 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 Feb 22, 2017
MEG-TORQ
K161500
Micro-Nx Co., Ltd.
Dental · 266d
Cleared Sep 27, 2016
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
K160825
Dentsply Sirona
Dental · 186d
Cleared Aug 12, 2016
EMS-200
K153285
Meta Systems Co., Ltd.
Dental · 274d
Cleared Jan 07, 2016
Tellos ISQ Buddy
K143445
Tellos Medical AB
Dental · 401d
Cleared Jun 29, 2015
TRAUS ENDO
K143411
Saeshin Precision Co., Ltd.
Dental · 213d
Cleared May 28, 2015
AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
K150129
Aseptico, Inc.
Dental · 127d
Cleared Feb 19, 2015
Osstell IDx
K142358
Osstell AB
Dental · 178d
Cleared Dec 31, 2014
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
K142124
Aseptico, Inc.
Dental · 149d
Cleared Sep 19, 2014
ENDO SMART
K133298
Meta Biomed, Inc.
Dental · 329d
Cleared Apr 09, 2014
MEGA ISQ
K132401
Osstell AB
Dental · 251d
Cleared Sep 12, 2013
IPROPHY MOBILE
K131578
Nakanishi, Inc.
Dental · 104d
Cleared Aug 16, 2013
ENDO A CLASS
K123582
Saeyang Microtech Co., Ltd.
Dental · 269d
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 Aug 19, 2011
E-CUBE
K111616
Saeshin Precision Co., Ltd.
Dental · 70d
Cleared Jun 14, 2011
AEU-26L ELCTRONIC ENDODONTIC SYSTEM
K111078
Aseptico, Inc.
Dental · 57d
Cleared Jun 06, 2011
MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
K110753
Dentsply International, Inc.
Dental · 80d
Cleared Feb 28, 2011
GENERAL DENISTRY MOTOR
K103399
Aseptico, Inc.
Dental · 101d
Cleared Jul 09, 2010
PROSTHODONTIC SCREWDRIVER , MODEL IA-400
K100600
W&H Dentalwerk Buermoos GmbH
Dental · 128d