BEUDAMED
    Product Code: EBW FDA class 1 21 CFR 872.4200

    Controller, Foot, Handpiece And Cord

    Dental

    The Handpiece and Cord Foot Controller is a dental device consisting of a foot-operated pedal that controls the activation, speed, and direction of a dental handpiece or other dental unit functions, allowing the clinician to operate the handpiece hands-free. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EBW and the applicable regulation is 21 CFR 872.4200, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    61
    FEI Numbers
    69
    Registration Numbers
    69
    Unique Applicants
    40
    Years Active
    49

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    Basic Information

    Product Code
    EBW
    Device Class
    FDA class 1
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 61 510(k) clearances via K numbers.

    K Number Device Name
    K251407 Motor Handpiece and Control Unit (SDI10)
    K251701 Star E900 Electric System
    K251811 Motor and Apex Module (MaAM)
    K231562 ELEC ENGINE (Model: ISE-170L)
    K242646 Dental Implant Unit
    K233288 NLZ Built-In Motor System
    K233117 Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
    K230895 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,
    K231864 Fiber Optic Brushless Electronic Micromotor, model: iM100
    K211358 Implanter incl. Accessories
    K220831 Dental Implantation Systems, Dental Electrical Motors
    K213022 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
    K202075 Dental Electric Motor
    K201191 ELEC-LED
    K203706 Dental Electric Motor
    K201192 Impla-NX (Model: ISE-270M)
    K201292 TRAUS SIP20
    K193341 iCTmotor (WL-1)
    K180845 Maxima Electric System
    K181858 Electric Handpiece Motor
    K173905 Surgic Pro, Surgic Pro+
    K163402 NLZ Motor System
    K163131 A-dec NLZ Electric Motor System
    K163317 ELECTROmatic
    K161213 XSmart iQ
    K161957 W&H Implantmed SI-1015 incl. Accessories
    K141482 KI-20
    K140308 MASTERSURG / EXPERTSURG
    K133776 A-DEC/W&H ELECTRIC HANDPIECE MOTOR
    K132570 ELECTRIC HANDPIECE SYSTEM
    K123608 ENDO E CLASS
    K111623 I-ENDO DUAL
    K103027 ELECTROTORQUE TLC
    K103653 E3 TORQUE CONTROL MOTOR
    K102241 ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
    K100785 BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
    K092214 CHIROPRO L SYSTEM
    K092758 X-CUBE
    K090727 IMM DENTAL IRRIGATION TUBING SET
    K090937 E-STATIS 40 SYSTEM
    K083252 NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
    K060287 DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
    K052741 IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES
    K041124 IRRIGATION TUBING SET 2.2M AND 3.8M
    K040153 I-TEC PORTABLE DENTAL OPERATORY
    K032572 A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
    K031584 SIROTORQUE L
    K014068 ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
    K020327 SURGIC IV IMPLANT CONTROL UNIT
    K011926 ELEC-MATE E
    K002469 IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
    K000120 PRO-TORQ
    K992648 ROTARY MASTER
    K990954 ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
    K972889 ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)
    K972924 SURGIC II IMPLANT CONTROL UNIT
    K964860 MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
    K964863 MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
    K905620 MODIFIED SITE PERISTALTIC FOOTSWITCH
    K790322 OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
    K770129 SPRINT S-2 INSTRU. CENTER (MODEL 92329)

    FEI Numbers

    This FDA classification entry is associated with 69 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 69 registration numbers. Click on an entry to view related FDA registrations.