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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: EFB FDA class 1

    Handpiece, Air-Powered, Dental

    Dental

    View full classification →

    The Air-Powered Dental Handpiece is a dental device driven by compressed air that rotates dental burs at high or low speeds for cutting tooth structure, removing decay, and finishing restorations. 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 EFB 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
    Synea Fusion Handpieces (Intensiv & Profin)
    Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
    High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
    Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
    High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
    Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
    High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
    EVO 700 series high speed handpiece
    Titanium Turbine
    TRAUS Air Dental Handpiece
    Medidenta High Speed Handpieces
    Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
    Dental Air Polishing Handpiece
    OK Handpiece
    Stainless Turbine
    Highspeed Airturbine Handpiece
    Dental Low-speed Handpieces and Accessories
    Disposable High Speed Air Turbine Handpiece
    High-speed air turbine handpiece / Low-speed air turbine handpiece
    Lubrina 2
    Midwest Rhino XE and Air Motor M
    SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
    EVO 450 series High Speed Handpieces
    Dental high speed handpiece, Dental low speed handpiece
    PROPHYflex 4
    Dental High-speed Handpiece and Accessories
    High-speed Turbine Handpieces for Single Use
    Concentrix MX-AC High-Speed Handpiece
    PERIO-FLOW nozzle
    W&H Assistina Twin
    Dental Low-speed Turbine Handpiece
    Dental High-speed Turbine Handpiece
    Premium Plus Prophy Air Motor
    PANA SPRAY Plus
    Air-Powered Handpieces and Handpiece Attachments
    WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head
    430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
    AIR-FLOW handy 3.0 PLUS
    High Speed Handpieces and Accessories
    Advanced Air System
    MDK HANDPIECES
    Maxima PRO 45L
    Codent Low Speed Dental Handpieces and Accessories
    EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
    Maxima XTEND Handpiece Maintenance System
    LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR
    #8C RENEGADE DENTAL HANDPIECE
    CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
    T1/T2/T3 TURBINE FAMILY
    AIR-FLOW HANDY 3.0

    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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