Controller, Foot, Handpiece And Cord

FDA product code EBW · 57 cleared devices

Class 1 Dental

Regulation: 21 CFR 872.4200
Review panel: DE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-01-28 – 2026-01-30

EBW 2026-01-30

Motor Handpiece and Control Unit (SDI10)

Applicant Saeshin Precision Co., Ltd.

K number K251407

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EBW 2026-01-12

Star E900 Electric System

Applicant Dentalez, Inc., Stardental Division

K number K251701

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EBW 2025-08-25

Motor and Apex Module (MaAM)

Applicant Dentsply Sirona, Inc.

K number K251811

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EBW 2025-07-18

ELEC ENGINE (Model: ISE-170L)

Applicant Micro-Nx Co., Ltd.

K number K231562

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EBW 2025-04-11

Dental Implant Unit

Applicant Guilin Aesthedent Medical Instruments Co., Ltd.

K number K242646

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EBW 2024-06-24

NLZ Built-In Motor System

Applicant Nakanishi, Inc.

K number K233288

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EBW 2024-06-20

Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)

Applicant Nakanishi, Inc.

K number K233117

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EBW 2024-04-01

CEFLA 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,

Applicant Cefla S.C.

K number K230895

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EBW 2024-03-11

Fiber Optic Brushless Electronic Micromotor, model: iM100

Applicant Codent Technical Industry Co., Ltd.

K number K231864

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EBW 2022-11-21

Implanter incl. Accessories

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K number K211358

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EBW 2022-09-27

Dental Implantation Systems, Dental Electrical Motors

Applicant Foshan Coxo Medical Instrument Co., Ltd.

K number K220831

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EBW 2022-05-09

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED

Applicant Cefla S.C.

K number K213022

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EBW 2022-03-11

Dental Electric Motor

Applicant Foshan Cicada Dental Instrument Co, Ltd.

K number K202075

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EBW 2022-02-07

ELEC-LED

Applicant Micro-Nx Co., Ltd.

K number K201191

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EBW 2022-01-13

Dental Electric Motor

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K number K203706

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EBW 2021-05-21

Impla-NX (Model: ISE-270M)

Applicant Micro-Nx Co., Ltd.

K number K201192

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EBW 2021-02-11

TRAUS SIP20

Applicant Saeshin Precision Co., Ltd.

K number K201292

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EBW 2020-09-04

iCTmotor (WL-1)

Applicant Dentium Co., Ltd.

K number K193341

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EBW 2019-07-25

Maxima Electric System

Applicant Handpiece Headquarters - Hpr, Inc.

K number K180845

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EBW 2019-03-26

Electric Handpiece Motor

Applicant W&H Dentalwerk Buermoos GmbH

K number K181858

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EBW 2018-06-19

Surgic Pro, Surgic Pro+

Applicant Nakanishi, Inc.

K number K173905

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EBW 2017-08-31

NLZ Motor System

Applicant Nakanishi, Inc.

K number K163402

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EBW 2017-05-11

A-dec NLZ Electric Motor System

Applicant Nakanishi, Inc.

K number K163131

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EBW 2017-02-21

ELECTROmatic

Applicant Kaltenbach & Voigt Gmgh

K number K163317

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EBW 2017-02-10

XSmart iQ

Applicant Dentsply Sirona

K number K161213

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EBW 2016-11-23

W&H Implantmed SI-1015 incl. Accessories

Applicant W&H Dentalwerk Burmoos GmbH

K number K161957

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EBW 2013-08-16

ENDO E CLASS

Applicant Saeyang Microtech Co., Ltd.

K number K123608

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EBW 2012-01-10

I-ENDO DUAL

Applicant Satelec - Acteon Group

K number K111623

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EBW 2011-08-19

ELECTROTORQUE TLC

Applicant Kaltenbach & Voigt GmbH

K number K103027

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EBW 2011-05-26

E3 TORQUE CONTROL MOTOR

Applicant Dentsply International, Inc.

K number K103653

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EBW 2011-03-23

ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT

Applicant Anthogyr Sas

K number K102241

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EBW 2010-12-03

BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES

Applicant Bonart Co., Ltd.

K number K100785

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EBW 2009-12-15

CHIROPRO L SYSTEM

Applicant Bien-Air Dental, SA

K number K092214

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EBW 2009-09-21

X-CUBE

Applicant Saeshin Precision Co., Ltd.

K number K092758

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EBW 2009-08-13

IMM DENTAL IRRIGATION TUBING SET

Applicant Innovative Medical Manufacturing Co.

K number K090727

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EBW 2009-07-24

E-STATIS 40 SYSTEM

Applicant Scican , Ltd.

K number K090937

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EBW 2009-02-18

NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM

Applicant Dentalez Group, Stardental Division

K number K083252

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EBW 2006-05-03

DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM

Applicant W&H Dentalwerk Buermoos GmbH

K number K060287

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EBW 2006-01-13

IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES

Applicant W&H Dentalwerk Buermoos GmbH

K number K052741

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EBW 2004-06-07

IRRIGATION TUBING SET 2.2M AND 3.8M

Applicant W&H Dentalwerk Burmoos

K number K041124

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EBW 2004-05-21

I-TEC PORTABLE DENTAL OPERATORY

Applicant Indigenous Peoples Technology and Education Center

K number K040153

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EBW 2003-12-03

A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT

Applicant A-Dec, Inc.

K number K032572

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EBW 2003-08-19

SIROTORQUE L

Applicant Sirona Dental Systems GmbH

K number K031584

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EBW 2002-05-03

ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115

Applicant W&H Dentalwerk Buermoos GmbH

K number K014068

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EBW 2002-04-08

SURGIC IV IMPLANT CONTROL UNIT

Applicant Nakanishi, Inc.

K number K020327

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EBW 2001-09-11

ELEC-MATE E

Applicant Nakanishi, Inc.

K number K011926

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EBW 2001-02-07

IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)

Applicant W&H Dentalwerk Buermoos GmbH

K number K002469

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EBW 2000-02-03

PRO-TORQ

Applicant Micro Motors, Inc.

K number K000120

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EBW 2000-01-31

ROTARY MASTER

Applicant J. Morita USA, Inc.

K number K992648

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EBW 1999-06-09

ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET

Applicant Nsk Nakanishi, Inc.

K number K990954

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EBW 1998-01-22

ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)

Applicant W & H Dentalwerk

K number K972889

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EBW 1997-10-30

SURGIC II IMPLANT CONTROL UNIT

Applicant Nsk Nakanishi, Inc.

K number K972924

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EBW 1997-03-03

MARK 20 AND MARK 25 HAND ENGINE CONTROLLER

Applicant Bell Intl., Inc.

K number K964860

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EBW 1997-02-28

MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN

Applicant Bell Intl., Inc.

K number K964863

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EBW 1991-02-27

MODIFIED SITE PERISTALTIC FOOTSWITCH

Applicant Site Microsurgical Systems, Inc.

K number K905620

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EBW 1979-05-14

OPTIONAL ACCESSORY FOOT SWITCH MODEL 100

Applicant Applied Medical Research

K number K790322

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EBW 1977-01-28

SPRINT S-2 INSTRU. CENTER (MODEL 92329)

Applicant Chemetron Health Systems

K number K770129

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