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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: MUH FDA class 2

    System, X-Ray, Extraoral Source, Digital

    Dental

    View full classification →

    A Digital Extraoral Source X-Ray System is a dental radiographic imaging system that captures digital X-ray images of the teeth, jaws, and surrounding structures from outside the mouth, including panoramic and cephalometric systems, used for dental diagnosis and treatment planning. It is FDA Class 2, requiring 510(k) clearance, with product code MUH under 21 CFR 872.1800 in the Dental specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
    X Sensor (Model: IOS-A15IF, HDI-15DGF)
    DUO1 and DUO2
    RAYSCAN a-Expert
    Digital image scanner of dental
    DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
    TuxDeluxe (Size 1 6100B, Size 2 6101B)
    Digital Wireless Intraoral X-Ray Sensor
    WeSensor
    EZSensor XHD
    GenX-CR
    QuickRayPRO
    Digital Intraoral X-Ray Sensor
    Eagle S/Saevo Slim/D700 Slim
    ScanX Swift 2.0, ScanX Swift View 2.0
    Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
    HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
    PAPAYA & PAPAYA Plus
    OpenSensorX Series
    Dental sensors NanoPix1, NanoPix2
    Dental Image Plate Scanner, Model DFC-4T-SMART
    Digital Intraoral X-ray Sensor
    JAZZ Solo sensor
    Digital Intraoral X-ray Imaging System
    Imaging Plate Scanner, i-Scan
    RXS 1000
    StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
    CRUXVIEW
    DC-Air and Athlos-1 and Athlos-Air
    PlutoX Digital Intraoral X-Ray Imaging System
    SensorX
    X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
    Clio Prime and Clio Pedo
    ScanX Edge
    I-View Gold and Imagen Gold Dental Sensors
    R-Sensor, R-Sensor
    X-MIND Trium
    Digital Intraoral Imaging Plate System
    ScanX Touch/ScanX Duo Touch
    ODI HD Dental Sensor
    Cruxcan (CRX-1000)
    Panoura X-ERA PF/NF/MF
    DENTIOIII series (DENTIOIII, DENTIOIII-S)
    Aurora
    Televere Digital Dental Imaging System
    FS Ergo
    DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
    Cocoon Portable Handheld X-Ray System
    Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
    ScanX Intraoral View

    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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