Atlas FDA

EBW

61 FDA 510(k) clearances · Product code

180 daysmedian time to decision
382 days90th percentile
61clearances measured

FDA profile

Official device name
Controller, Foot, Handpiece And Cord
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2018: 46 · 2019: 55 · 2020: 71 · 2021: 57 · 2022: 31 · 2023: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Motor Handpiece and Control Unit (SDI10) (K251407)Saeshin Precision Co., Ltd.2026-01-30
Star E900 Electric System (K251701)Dentalez, Inc., Stardental Division2026-01-12
Motor and Apex Module (MaAM) (K251811)Dentsply Sirona, Inc.2025-08-25
ELEC ENGINE (Model: ISE-170L) (K231562)Micro-Nx Co., Ltd.2025-07-18
Dental Implant Unit (K242646)Guilin Aesthedent Medical Instruments Co., Ltd.2025-04-11
NLZ Built-In Motor System (K233288)Nakanishi, Inc.2024-06-24
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (K233117)Nakanishi, Inc.2024-06-20
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, (K230895)Cefla S.C.2024-04-01
Fiber Optic Brushless Electronic Micromotor, model: iM100 (K231864)Codent Technical Industry Co., Ltd.2024-03-11
Implanter incl. Accessories (K211358)Guilin Woodpecker Medical Instrument Co., Ltd.2022-11-21
Dental Implantation Systems, Dental Electrical Motors (K220831)Foshan Coxo Medical Instrument Co., Ltd.2022-09-27
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED (K213022)Cefla S.C.2022-05-09
Dental Electric Motor (K202075)Foshan Cicada Dental Instrument Co, Ltd.2022-03-11
ELEC-LED (K201191)Micro-Nx Co., Ltd.2022-02-07
Dental Electric Motor (K203706)Guilin Woodpecker Medical Instrument Co., Ltd.2022-01-13
Impla-NX (Model: ISE-270M) (K201192)Micro-Nx Co., Ltd.2021-05-21
TRAUS SIP20 (K201292)Saeshin Precision Co., Ltd.2021-02-11
iCTmotor (WL-1) (K193341)Dentium Co., Ltd.2020-09-04
Maxima Electric System (K180845)Handpiece Headquarters - Hpr, Inc.2019-07-25
Electric Handpiece Motor (K181858)W&H Dentalwerk Buermoos GmbH2019-03-26
Surgic Pro, Surgic Pro+ (K173905)Nakanishi, Inc.2018-06-19
NLZ Motor System (K163402)Nakanishi, Inc.2017-08-31
A-dec NLZ Electric Motor System (K163131)Nakanishi, Inc.2017-05-11
ELECTROmatic (K163317)Kaltenbach & Voigt Gmgh2017-02-21
XSmart iQ (K161213)Dentsply Sirona2017-02-10
W&H Implantmed SI-1015 incl. Accessories (K161957)W&H Dentalwerk Burmoos GmbH2016-11-23
KI-20 (K141482)Saeyang Microtech Co., Ltd.2015-04-24
MASTERSURG / EXPERTSURG (K140308)Kaltenbach & Voigt GmbH2014-08-15
A-DEC/W&H ELECTRIC HANDPIECE MOTOR (K133776)A-Dec, Inc.2014-05-28
ELECTRIC HANDPIECE SYSTEM (K132570)Ttbio Corp.2014-04-29
ENDO E CLASS (K123608)Saeyang Microtech Co., Ltd.2013-08-16
I-ENDO DUAL (K111623)Satelec - Acteon Group2012-01-10
ELECTROTORQUE TLC (K103027)Kaltenbach & Voigt GmbH2011-08-19
E3 TORQUE CONTROL MOTOR (K103653)Dentsply International, Inc.2011-05-26
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT (K102241)Anthogyr Sas2011-03-23
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES (K100785)Bonart Co., Ltd.2010-12-03
CHIROPRO L SYSTEM (K092214)Bien-Air Dental, SA2009-12-15
X-CUBE (K092758)Saeshin Precision Co., Ltd.2009-09-21
IMM DENTAL IRRIGATION TUBING SET (K090727)Innovative Medical Manufacturing Co.2009-08-13
E-STATIS 40 SYSTEM (K090937)Scican , Ltd.2009-07-24
NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM (K083252)Dentalez Group, Stardental Division2009-02-18
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM (K060287)W&H Dentalwerk Buermoos GmbH2006-05-03
IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES (K052741)W&H Dentalwerk Buermoos GmbH2006-01-13
IRRIGATION TUBING SET 2.2M AND 3.8M (K041124)W&H Dentalwerk Burmoos2004-06-07
I-TEC PORTABLE DENTAL OPERATORY (K040153)Indigenous Peoples Technology and Education Center2004-05-21
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT (K032572)A-Dec, Inc.2003-12-03
SIROTORQUE L (K031584)Sirona Dental Systems GmbH2003-08-19
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 (K014068)W&H Dentalwerk Buermoos GmbH2002-05-03
SURGIC IV IMPLANT CONTROL UNIT (K020327)Nakanishi, Inc.2002-04-08
ELEC-MATE E (K011926)Nakanishi, Inc.2001-09-11
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) (K002469)W&H Dentalwerk Buermoos GmbH2001-02-07
PRO-TORQ (K000120)Micro Motors, Inc.2000-02-03
ROTARY MASTER (K992648)J. Morita USA, Inc.2000-01-31
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET (K990954)Nsk Nakanishi, Inc.1999-06-09
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) (K972889)W & H Dentalwerk1998-01-22
SURGIC II IMPLANT CONTROL UNIT (K972924)Nsk Nakanishi, Inc.1997-10-30
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER (K964860)Bell Intl., Inc.1997-03-03
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN (K964863)Bell Intl., Inc.1997-02-28
MODIFIED SITE PERISTALTIC FOOTSWITCH (K905620)Site Microsurgical Systems, Inc.1991-02-27
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 (K790322)Applied Medical Research1979-05-14
SPRINT S-2 INSTRU. CENTER (MODEL 92329) (K770129)Chemetron Health Systems1977-01-28

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