BEUDAMED
    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: EHD FDA class 2

    Unit, X-Ray, Extraoral With Timer

    Dental

    View full classification →

    The Extraoral X-Ray Unit with Timer is a dental imaging system used to capture panoramic, cephalometric, or other extraoral radiographic views of the jaws, skull, and surrounding structures, with an integrated timer to control exposure duration. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance and compliance with special controls. The product code is EHD, regulated under 21 CFR 872.1800 in the Dental (DE) specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Portable Dental X-ray System Model PDX nova
    NOMAD Pro 3
    Dental X-RAY Unit (AJX200)
    Portable Dental X-ray Device (GT-1)
    Diagnostic X-Ray Equipment Model POCT22
    Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
    Rextar Pro
    XERO-alpha
    WERAY
    LifeRay Intraoral Handheld X-ray System
    REMEX-GR100
    XVbeam2000
    Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
    x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
    DVAS (DVAS-M, DVAS-W)
    N1
    HyperLight Portable X-ray Unit
    Portable X-ray System Model Ray98(P)
    Lumos 3DX
    DHX-70H, XTG-70H
    Portable X-ray System
    Ai Ray Dental X-Ray Device
    EzRay Air 2 Wall (Model: VEX-S350W)
    Hybrid C70
    FONA XDC
    CLAROX
    DT-703
    HYBRID S70
    ERI Handheld Dental X-ray System (Model AG100)
    Portray
    Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)
    EzRay Air Portable (Model: VEX-P300)
    Xcam
    EZER, Portable X-ray System
    MINE
    Star-X, Intraoral X-ray System
    RiX70 DC
    Portable X-ray System (Model: MiniX-V, Mini X-S)
    MobileX Portable X-ray System
    Portable X-ray System
    PORT-X IV
    KaVo NOMAD Pro 2 Handheld X-ray System
    Intraskan DC Plus
    EzRay Air W
    RX DC
    EzRay Air (Model VEX-P300)
    BI IMAGE-X EVOLUTION
    Portable X-ray System (Model: MINIX-V / MINIX-S)
    PHOT-X IIS MODEL 505
    PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump