FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K033597 |
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. |
ATR 5000, LC 5000, IMPLANT SYSTEM |
11/25/2003 |
K041279 |
ANTHOGYR |
IMPLANTEO IMPLANTOLOGY MOTOR |
09/23/2004 |
K082325 |
APEXUM LTD. |
APEXUM ABLATOR |
04/21/2009 |
K111078 |
ASEPTICO, INC. |
AEU-26L ELCTRONIC ENDODONTIC SYSTEM |
06/14/2011 |
K142124 |
ASEPTICO, INC. |
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM |
12/31/2014 |
K150129 |
Aseptico, Inc. |
AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) |
05/28/2015 |
K030163 |
ASEPTICO, INC. |
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 |
03/03/2003 |
K103399 |
ASEPTICO, INC. |
GENERAL DENISTRY MOTOR |
02/28/2011 |
K091913 |
BY DENTAL SRL |
HI TECH IMPLANT, HT PHYSIO IMPLANT |
10/30/2009 |
K191276 |
ChangZhou BoMedent Medical Technology Co., Ltd. |
Dental Electrical Motor iRoot Pro |
06/30/2020 |
K201993 |
Changzhou Sifary Medical Technology Co., Ltd. |
E-connect S Endo Motor with built-in Apex Locator |
01/29/2021 |
K092833 |
DENTAMERICA |
ENDOMAX CORDLESS ENDODONTIC HANDPIECE |
01/07/2010 |
K110753 |
DENTSPLY INTERNATIONAL, INC. |
MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM |
06/06/2011 |
K092614 |
DENTSPLY INTERNTIONAL |
X-SMART EASY |
12/02/2009 |
K160825 |
DENTSPLY SIRONA |
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology |
09/27/2016 |
K101612 |
DISCUS DENTAL, LLC |
ZEN CORDLESS PROPHY SYSTEM |
06/30/2010 |
K180953 |
DMS Co., Ltd. |
AnyCheck IMT-100 |
02/20/2019 |
K192649 |
Foshan CICADA Dental Instrument Co., Ltd. |
Endo Motor |
03/12/2021 |
K220829 |
Foshan COXO Medical Instrument Co., Ltd. |
Endo Motor |
05/18/2023 |
K211531 |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Cordless Prophy System, Model: i-Polish |
12/17/2021 |
K203320 |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Endo Motor |
05/10/2021 |
K180527 |
Hiossen, Inc. |
IS3 |
05/16/2018 |
K033689 |
INTEGRATION DIAGNOSTICS LTD |
OSSTELL MENTOR RFA |
02/26/2004 |
K003714 |
INTEGRATION DIAGNOSTICS LTD |
OSSTELL RESONANCE FREQUENCY ANALYZER |
08/09/2001 |
K031204 |
J. MORITA USA, INC. |
DENTAPORT ZX |
08/21/2003 |
K173920 |
J. Morita USA, Inc. |
LS OIL |
10/11/2018 |
K071190 |
J. MORITA USA, INC. |
ROOT ZX II |
08/17/2007 |
K112665 |
J. MORITA USA, INC. |
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE |
05/04/2012 |
K970339 |
J. MORITA USA, INC. |
TRI AUTO ZX |
06/04/1997 |
K170275 |
J. MORITA USA, INC. |
Tri Auto ZX2 |
09/11/2017 |
K031540 |
LARES RESEARCH, INC. |
APEX ELECTRIC HANDPIECE SYSTEM |
06/30/2003 |
K050612 |
LIGHTSPEED TECHNOLOGY, INC. |
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE |
05/04/2005 |
K012944 |
MEDITEAM AB |
POWER DRIVE |
11/20/2001 |
K133298 |
META BIOMED, INC. |
ENDO SMART |
09/19/2014 |
K210475 |
Meta Systems Co., Ltd |
EQ-M |
09/21/2022 |
K153285 |
META SYSTEMS CO., LTD. |
EMS-200 |
08/12/2016 |
K161500 |
MICRO-NX Co., Ltd |
MEG-TORQ |
02/22/2017 |
K110278 |
NAKANISHI, INC. |
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 |
02/15/2012 |
K131578 |
NAKANISHI, INC. |
IPROPHY MOBILE |
09/12/2013 |
K081191 |
NOUVAG AG |
TCM ENDO 20 |
08/07/2008 |
K042822 |
NOUVAG AG |
TCM ENDO V, MODEL 1534 |
12/22/2004 |
K990646 |
NSK NAKANISHI, INC. |
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE |
03/19/1999 |
K990682 |
NSK NAKANISHI, INC. |
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) |
03/24/1999 |
K132401 |
OSSTELL AB |
MEGA ISQ |
04/09/2014 |
K181888 |
Osstell AB |
Osstell Beacon |
08/22/2019 |
K142358 |
OSSTELL AB |
Osstell IDx |
02/19/2015 |
K082523 |
OSSTELL AB |
OSSTELL ISQ IMPLANT STABILITY METER |
09/26/2008 |
K983413 |
PARKELL, INC. |
MODEL MS-1 HANDPIECE |
12/21/1998 |
K232657 |
Perimetrics, Inc |
InnerView LC |
09/01/2023 |
K072213 |
PERIMETRICS, INC. |
PERIMETRICS PERIOMETER |
08/29/2008 |
K993188 |
PHYTRON- ELEKTRONIK GMBH |
ENDOSTEPPER 1 |
09/28/1999 |
K180682 |
Premier Dental Company Products |
AeroPro Cordless Prophy System |
02/27/2019 |
K111616 |
SAESHIN PRECISION CO., LTD. |
E-CUBE |
08/19/2011 |
K212043 |
Saeshin Precision Co., Ltd. |
TRAUS ENDO |
06/24/2022 |
K143411 |
SAESHIN PRECISION CO., LTD. |
TRAUS ENDO |
06/29/2015 |
K123582 |
SAEYANG MICROTECH CO., LTD |
ENDO A CLASS |
08/16/2013 |
K213897 |
Saeyang Microtech Co., Ltd. |
Pro M Class |
09/19/2022 |
K222548 |
Shenzhen Perfect Medical Instruments Co., Ltd. |
Endo Motor |
04/26/2023 |
K051661 |
SIRONA DENTAL SYSTEMS GMBH |
IMPLANT HANDPIECES |
09/06/2005 |
K052515 |
SIRONA DENTAL SYSTEMS GMBH |
SIROENDO |
03/31/2006 |
K990739 |
SYBRON DENTAL SPECIALTIES, INC. |
QUANTEC-E ENDO SYSTEM |
05/26/1999 |
K143445 |
Tellos Medical AB |
Tellos ISQ Buddy |
01/07/2016 |
K090931 |
W & H DENTALWERK BUERMOOS GMBH |
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR |
12/15/2009 |
K100600 |
W & H DENTALWERK BUERMOOS GMBH |
PROSTHODONTIC SCREWDRIVER , MODEL IA-400 |
07/09/2010 |
K201703 |
W&H Dentalwerk Buermoos GmbH |
PROXEO Twist Cordless Polishing System PL-40 H |
02/24/2021 |
K063007 |
WESTPORT MEDICAL, INC. |
POWERTOME PERIOTOME |
10/17/2006 |
K171377 |
Young Dental Manufacturing Co 1, LLC |
Young INFINITY Cordless Handpiece System |
08/20/2018 |