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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: OAS FDA class 2

    X-Ray, Tomography, Computed, Dental

    Radiology

    View full classification →

    The X-Ray, Tomography, Computed, Dental (product code OAS) is a dental computed tomography (CT) imaging system used to produce cross-sectional diagnostic X-ray images of intraoral tissue and teeth, supporting diagnosis and treatment planning in dentistry and oral surgery. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 892.1750 within the Radiology specialty. The device carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Dental CBCT X-ray System
    Dental Cone Beam Computed Tomography System
    RCT600
    Green X 12 SE (PHT-40CHS)
    Green X 21 (PHT-90CHO)
    Dental Cone-beam Computed Tomography (FinScan F350)
    Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)
    T2 Plus
    Dental Cone-beam Computed Tomography
    Dental Cone-beam Computed Tomography
    Planmeca Viso
    bright CT
    Provecta 3D Prime and Provecta 3D Prime Ceph
    PreXion3D Expedition
    RAYSCAN a-Expert3D
    Grreen X 12 (Model: PHT-75CHS)
    X-View 3D Pan/X-View 2D Pan
    Orthopantomograph™ OP 3D LX
    RCT800
    Dental CT Scanner AXR
    hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
    PreXion3D Expedition
    R2 Studio Q/RCT820
    PreXion3D Explorer PRO
    PAPAYA 3D & PAPAYA 3D Plus
    Planmed Verity
    Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
    hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
    eco-x Series (eco-x, eco-x-s)
    RCT700
    DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
    T2
    EAGLE EDGE AXR90 and AXR120
    rainbow CT
    rainbow MCT
    PreXion3D Explorer PRO
    Green X 18(Model : PHT-75CHS)
    3D Accuitomo 150N
    vatech A9 (Model : PHT-30CSS)
    X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
    Dental Computed Tomography X-Ray System, Green X
    PAPAYA 3D Premium & PAPAYA 3D Premium Plus
    Midmark Extraoral Imaging System (EOIS)
    Axeos
    PreXion3D Explorer EX
    hyperion X5, NewTom GO, X-RADiUS COMPACT
    CS 9600
    ProVecta 3D Prime Ceph
    RCT800
    SeeFactorCT3

    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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