EKX · Class I · 21 CFR 872.4200

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

Leading manufacturers include J. Morita USA, Inc., Osstell AB and Aseptico, Inc..

90
Total
90
Cleared
182d
Avg days
1976
Since
90 devices
25–48 of 90
Cleared Feb 27, 2019
AeroPro Cordless Prophy System
K180682
Premier Dental Company Products
Dental · 349d
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