FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K133776 |
A-DEC, INC. |
A-DEC/W&H ELECTRIC HANDPIECE MOTOR |
05/28/2014 |
K032572 |
A-DEC, INC. |
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT |
12/03/2003 |
K102241 |
ANTHOGYR SAS |
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT |
03/23/2011 |
K964860 |
BELL INTL., INC. |
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER |
03/03/1997 |
K964863 |
BELL INTL., INC. |
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN |
02/28/1997 |
K092214 |
BIEN-AIR DENTAL, SA |
CHIROPRO L SYSTEM |
12/15/2009 |
K100785 |
BONART CO. LTD. |
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES |
12/03/2010 |
K213022 |
CEFLA S.C. |
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED |
05/09/2022 |
K083252 |
DENTALEZ GROUP, STARDENTAL DIVISION |
NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM |
02/18/2009 |
K193341 |
Dentium Co., Ltd |
iCTmotor (WL-1) |
09/04/2020 |
K103653 |
DENTSPLY INTERNATIONAL INC. |
E3 TORQUE CONTROL MOTOR |
05/26/2011 |
K161213 |
DENTSPLY SIRONA |
XSmart iQ |
02/10/2017 |
K202075 |
Foshan CICADA Dental Instrument Co, Ltd. |
Dental Electric Motor |
03/11/2022 |
K220831 |
Foshan COXO Medical Instrument Co., Ltd. |
Dental Implantation Systems, Dental Electrical Motors |
09/27/2022 |
K203706 |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Dental Electric Motor |
01/13/2022 |
K211358 |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Implanter incl. Accessories |
11/21/2022 |
K180845 |
Handpiece Headquarters - HPR Inc. |
Maxima Electric System |
07/25/2019 |
K040153 |
INDIGENOUS PEOPLES TECHNOLOGY AND EDUCATION CENTER |
I-TEC PORTABLE DENTAL OPERATORY |
05/21/2004 |
K090727 |
INNOVATIVE MEDICAL MANUFACTURING CO. |
IMM DENTAL IRRIGATION TUBING SET |
08/13/2009 |
K992648 |
J. MORITA USA, INC. |
ROTARY MASTER |
01/31/2000 |
K103027 |
KALTENBACH & VOIGT GMBH |
ELECTROTORQUE TLC |
08/19/2011 |
K140308 |
KALTENBACH & VOIGT GMBH |
MASTERSURG / EXPERTSURG |
08/15/2014 |
K163317 |
Kaltenbach & Voigt GmgH |
ELECTROmatic |
02/21/2017 |
K000120 |
MICRO MOTORS, INC. |
PRO-TORQ |
02/03/2000 |
K201191 |
MICRO-NX Co., Ltd. |
ELEC-LED |
02/07/2022 |
K201192 |
MICRO-NX Co., Ltd. |
Impla-NX (Model: ISE-270M) |
05/21/2021 |
K163402 |
NAKANISHI INC. |
NLZ Motor System |
08/31/2017 |
K173905 |
Nakanishi Inc. |
Surgic Pro, Surgic Pro+ |
06/19/2018 |
K163131 |
NAKANISHI, INC. |
A-dec NLZ Electric Motor System |
05/11/2017 |
K011926 |
NAKANISHI, INC. |
ELEC-MATE E |
09/11/2001 |
K020327 |
NAKANISHI, INC. |
SURGIC IV IMPLANT CONTROL UNIT |
04/08/2002 |
K990954 |
NSK NAKANISHI, INC. |
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET |
06/09/1999 |
K972924 |
NSK NAKANISHI, INC. |
SURGIC II IMPLANT CONTROL UNIT |
10/30/1997 |
K201292 |
Saeshin Precision Co., Ltd. |
TRAUS SIP20 |
02/11/2021 |
K092758 |
SAESHIN PRECISION CO., LTD. |
X-CUBE |
09/21/2009 |
K141482 |
SAEYANG MICROTECH CO LTD |
KI-20 |
04/24/2015 |
K123608 |
SAEYANG MICROTECH CO., LTD |
ENDO E CLASS |
08/16/2013 |
K111623 |
SATELEC-ACTEON GROUP |
I-ENDO DUAL |
01/10/2012 |
K090937 |
SCICAN LTD. |
E-STATIS 40 SYSTEM |
07/24/2009 |
K031584 |
SIRONA DENTAL SYSTEMS GMBH |
SIROTORQUE L |
08/19/2003 |
K132570 |
TTBIO CORP. |
ELECTRIC HANDPIECE SYSTEM |
04/29/2014 |
K972889 |
W & H DENTALWERK |
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) |
01/22/1998 |
K060287 |
W & H DENTALWERK BUERMOOS GMBH |
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM |
05/03/2006 |
K014068 |
W & H DENTALWERK BUERMOOS GMBH |
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 |
05/03/2002 |
K052741 |
W & H DENTALWERK BUERMOOS GMBH |
IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES |
01/13/2006 |
K002469 |
W & H DENTALWERK BUERMOOS GMBH |
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) |
02/07/2001 |
K181858 |
W&H Dentalwerk Buermoos GmbH |
Electric Handpiece Motor |
03/26/2019 |
K041124 |
W&H DENTALWERK BURMOOS |
IRRIGATION TUBING SET 2.2M AND 3.8M |
06/07/2004 |
K161957 |
W&H DENTALWERK BURMOOS GMBH |
W&H Implantmed SI-1015 incl. Accessories |
11/23/2016 |