ClearanceBrief
Panels › Dental › Product code EBW · Class 1

Controller, Foot, Handpiece And Cord

Regulation 872.4200

3510(k)s in 12 months (62 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Get daily alerts for EBWSample briefCSV

Top companies in EBW

Company510(k)sRecalls
Nakanishi, Inc.70
W&H Dentalwerk Buermoos GmbH50
Micro-Nx Co., Ltd.30
Saeshin Precision Co., Ltd.30
A-Dec, Inc.20
Bell Intl., Inc.20
Cefla S.C.20
Dentsply Sirona20
Guilin Woodpecker Medical Instrument Co., Ltd.20
Kaltenbach & Voigt GmbH20
Decided510(k)Device and applicantCode
Oct 1, 2026K260027Firstar Dental Electric Motor
FDC Technology Industry Co.
EBW
Jan 30, 2026K251407Motor Handpiece and Control Unit (SDI10)
Saeshin Precision Co., Ltd., KR
EBW
Jan 12, 2026K251701Star E900 Electric System
Dentalez, Inc., Stardental Division
EBW
Aug 25, 2025K251811Motor and Apex Module (MaAM)
Dentsply Sirona, Inc.
EBW
Jul 18, 2025K231562ELEC ENGINE (Model: ISE-170L)
Micro-Nx Co., Ltd., KR
EBW
Apr 11, 2025K242646Dental Implant Unit
Guilin Aesthedent Medical Instruments Co., Ltd., CN
EBW
Jun 24, 2024K233288NLZ Built-In Motor System
Nakanishi, Inc., JP
EBW
Jun 20, 2024K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
Nakanishi, Inc., JP
EBW
Apr 1, 2024K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,
Cefla S.C., IT
EBW
Mar 11, 2024K231864Fiber Optic Brushless Electronic Micromotor, model: iM100
Codent Technical Industry Co., Ltd., TW
EBW
Nov 21, 2022K211358Implanter incl. Accessories
Guilin Woodpecker Medical Instrument Co., Ltd., CN
EBW
Sep 27, 2022K220831Dental Implantation Systems, Dental Electrical Motors
Foshan Coxo Medical Instrument Co., Ltd., CN
EBW
May 9, 2022K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
Cefla S.C., IT
EBW
Mar 11, 2022K202075Dental Electric Motor
Foshan Cicada Dental Instrument Co, Ltd., CN
EBW
Feb 7, 2022K201191ELEC-LED
Micro-Nx Co., Ltd., KR
EBW
Jan 13, 2022K203706Dental Electric Motor
Guilin Woodpecker Medical Instrument Co., Ltd., CN
EBW
May 21, 2021K201192Impla-NX (Model: ISE-270M)
Micro-Nx Co., Ltd., KR
EBW
Feb 11, 2021K201292TRAUS SIP20
Saeshin Precision Co., Ltd., KR
EBW
Sep 4, 2020K193341iCTmotor (WL-1)
Dentium Co., Ltd., KR
EBW
Jul 25, 2019K180845Maxima Electric System
Handpiece Headquarters - Hpr, Inc.
EBW
Mar 26, 2019K181858Electric Handpiece Motor
W&H Dentalwerk Buermoos GmbH, AT
EBW
Jun 19, 2018K173905Surgic Pro, Surgic Pro+
Nakanishi, Inc., JP
EBW
Aug 31, 2017K163402NLZ Motor System
Nakanishi, Inc., JP
EBW
May 11, 2017K163131A-dec NLZ Electric Motor System
Nakanishi, Inc., JP
EBW
Feb 21, 2017K163317ELECTROmatic
Kaltenbach & Voigt Gmgh, DE
EBW
Feb 10, 2017K161213XSmart iQ
Dentsply Sirona
EBW
Nov 23, 2016K161957W&H Implantmed SI-1015 incl. Accessories
W&H Dentalwerk Burmoos GmbH, AT
EBW
Apr 24, 2015K141482KI-20
Saeyang Microtech Co., Ltd.
EBW
Aug 15, 2014K140308MASTERSURG / EXPERTSURG
Kaltenbach & Voigt GmbH, DE
EBW
May 28, 2014K133776A-DEC/W&H ELECTRIC HANDPIECE MOTOR
A-Dec, Inc.
EBW
Apr 29, 2014K132570ELECTRIC HANDPIECE SYSTEM
Ttbio Corp., TW
EBW
Aug 16, 2013K123608ENDO E CLASS
Saeyang Microtech Co., Ltd.
EBW
Jan 10, 2012K111623I-ENDO DUAL
Satelec - Acteon Group
EBW
Aug 19, 2011K103027ELECTROTORQUE TLC
Kaltenbach & Voigt GmbH
EBW
May 26, 2011K103653E3 TORQUE CONTROL MOTOR
Dentsply International, Inc.
EBW
Mar 23, 2011K102241ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
Anthogyr Sas, FR
EBW
Dec 3, 2010K100785BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
Bonart Co., Ltd.
EBW
Dec 15, 2009K092214CHIROPRO L SYSTEM
Bien-Air Dental, SA
EBW
Sep 21, 2009K092758X-CUBE
Saeshin Precision Co., Ltd., KR
EBW
Aug 13, 2009K090727IMM DENTAL IRRIGATION TUBING SET
Innovative Medical Manufacturing Co.
EBW
Jul 24, 2009K090937E-STATIS 40 SYSTEM
Scican , Ltd., CA
EBW
Feb 18, 2009K083252NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
Dentalez Group, Stardental Division
EBW
May 3, 2006K060287DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
W&H Dentalwerk Buermoos GmbH, AT
EBW
Jan 13, 2006K052741IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES
W&H Dentalwerk Buermoos GmbH, AT
EBW
Jun 7, 2004K041124IRRIGATION TUBING SET 2.2M AND 3.8M
W&H Dentalwerk Burmoos, AT
EBW
May 21, 2004K040153I-TEC PORTABLE DENTAL OPERATORY
Indigenous Peoples Technology and Education Center
EBW
Dec 3, 2003K032572A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
A-Dec, Inc.
EBW
Aug 19, 2003K031584SIROTORQUE L
Sirona Dental Systems GmbH
EBW
May 3, 2002K014068ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
W&H Dentalwerk Buermoos GmbH, AT
EBW
Apr 8, 2002K020327SURGIC IV IMPLANT CONTROL UNIT
Nakanishi, Inc., JP
EBW

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.