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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: EBW FDA class 1

    Controller, Foot, Handpiece And Cord

    Dental

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Dental Implant Unit
    NLZ Built-In Motor System
    Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
    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,
    Fiber Optic Brushless Electronic Micromotor, model: iM100
    Implanter incl. Accessories
    Dental Implantation Systems, Dental Electrical Motors
    CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
    Dental Electric Motor
    ELEC-LED
    Dental Electric Motor
    Impla-NX (Model: ISE-270M)
    TRAUS SIP20
    iCTmotor (WL-1)
    Maxima Electric System
    Electric Handpiece Motor
    Surgic Pro, Surgic Pro+
    NLZ Motor System
    A-dec NLZ Electric Motor System
    ELECTROmatic
    XSmart iQ
    W&H Implantmed SI-1015 incl. Accessories
    KI-20
    MASTERSURG / EXPERTSURG
    A-DEC/W&H ELECTRIC HANDPIECE MOTOR
    ELECTRIC HANDPIECE SYSTEM
    ENDO E CLASS
    I-ENDO DUAL
    ELECTROTORQUE TLC
    E3 TORQUE CONTROL MOTOR
    ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
    BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
    CHIROPRO L SYSTEM
    X-CUBE
    IMM DENTAL IRRIGATION TUBING SET
    E-STATIS 40 SYSTEM
    NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
    DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
    IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES
    IRRIGATION TUBING SET 2.2M AND 3.8M
    I-TEC PORTABLE DENTAL OPERATORY
    A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
    SIROTORQUE L
    ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
    SURGIC IV IMPLANT CONTROL UNIT
    ELEC-MATE E
    IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
    PRO-TORQ
    ROTARY MASTER
    ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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