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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: EKX FDA class 1

    Handpiece, Direct Drive, Ac-Powered

    Dental

    View full classification →

    The AC-Powered Direct Drive Dental Handpiece is an electrically powered rotary instrument that directly drives a cutting bur or attachment without a belt or air turbine, offering precise speed control for restorative, surgical, and laboratory dental procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKX, regulated under 21 CFR 872.4200 in the Dental (DE) specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
    ChecQ (AC100)
    HPR Cordless Hygiene Handpiece
    The Trust
    X-Smart Pro; X-Smart Pro+
    EM-07 Cordless Endo Motor
    Dental Handpiece, Wireless Endodontic Handpiece, endoit
    InnerView LC
    Endo Motor
    Endo Motor
    EQ-M
    Pro M Class
    TRAUS ENDO
    Cordless Prophy System, Model: i-Polish
    Endo Motor
    Endo Motor
    PROXEO Twist Cordless Polishing System PL-40 H
    E-connect S Endo Motor with built-in Apex Locator
    Dental Electrical Motor iRoot Pro
    Osstell Beacon
    AeroPro Cordless Prophy System
    AnyCheck IMT-100
    LS OIL
    Young INFINITY Cordless Handpiece System
    IS3
    Tri Auto ZX2
    MEG-TORQ
    MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
    EMS-200
    Tellos ISQ Buddy
    TRAUS ENDO
    AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
    Osstell IDx
    AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
    ENDO SMART
    MEGA ISQ
    IPROPHY MOBILE
    ENDO A CLASS
    TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
    CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
    E-CUBE
    AEU-26L ELCTRONIC ENDODONTIC SYSTEM
    MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
    GENERAL DENISTRY MOTOR
    PROSTHODONTIC SCREWDRIVER , MODEL IA-400
    ZEN CORDLESS PROPHY SYSTEM
    ENDOMAX CORDLESS ENDODONTIC HANDPIECE
    CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
    X-SMART EASY
    HI TECH IMPLANT, HT PHYSIO IMPLANT

    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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