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
49–72 of 90
Cleared Jul 09, 2010
PROSTHODONTIC SCREWDRIVER , MODEL IA-400
K100600
W&H Dentalwerk Buermoos GmbH
Dental · 128d
Cleared Jun 30, 2010
ZEN CORDLESS PROPHY SYSTEM
K101612
Discus Dental, LLC
Dental · 21d
Cleared Jan 07, 2010
ENDOMAX CORDLESS ENDODONTIC HANDPIECE
K092833
Dentamerica
Dental · 114d
Cleared Dec 15, 2009
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
K090931
W&H Dentalwerk Buermoos GmbH
Dental · 257d
Cleared Dec 02, 2009
X-SMART EASY
K092614
Dentsply Interntional
Dental · 98d
Cleared Oct 30, 2009
HI TECH IMPLANT, HT PHYSIO IMPLANT
K091913
By Dental Srl
Dental · 122d
Cleared Apr 21, 2009
APEXUM ABLATOR
K082325
Apexum , Ltd.
Dental · 250d
Cleared Sep 26, 2008
OSSTELL ISQ IMPLANT STABILITY METER
K082523
Osstell AB
Dental · 24d
Cleared Aug 29, 2008
PERIMETRICS PERIOMETER
K072213
Perimetrics, Inc.
Dental · 386d
Cleared Aug 07, 2008
TCM ENDO 20
K081191
NOUVAG AG
Dental · 101d
Cleared Aug 17, 2007
ROOT ZX II
K071190
J. Morita USA, Inc.
Dental · 109d
Cleared Oct 17, 2006
POWERTOME PERIOTOME
K063007
Westport Medical, Inc.
Dental · 15d
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 May 04, 2005
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
K050612
Lightspeed Technology, Inc.
Dental · 55d
Cleared Dec 22, 2004
TCM ENDO V, MODEL 1534
K042822
NOUVAG AG
Dental · 71d
Cleared Sep 23, 2004
IMPLANTEO IMPLANTOLOGY MOTOR
K041279
Anthogyr
Dental · 133d
Cleared Feb 26, 2004
OSSTELL MENTOR RFA
K033689
Integration Diagnostics, Ltd.
Dental · 94d
Cleared Nov 25, 2003
ATR 5000, LC 5000, IMPLANT SYSTEM
K033597
Advanced Technology Research (A.T.R.) S.R.L.
Dental · 11d
Cleared Aug 21, 2003
DENTAPORT ZX
K031204
J. Morita USA, Inc.
Dental · 127d
Cleared Jun 30, 2003
APEX ELECTRIC HANDPIECE SYSTEM
K031540
Lares Research, Inc.
Dental · 45d
Cleared Mar 03, 2003
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925
K030163
Aseptico, Inc.
Dental · 46d
Cleared Nov 20, 2001
POWER DRIVE
K012944
Mediteam AB
Dental · 77d
Cleared Aug 09, 2001
OSSTELL RESONANCE FREQUENCY ANALYZER
K003714
Integration Diagnostics, Ltd.
Dental · 251d