BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Ai Ray Dental X-Ray Device

    K Number: K222569 · Decision Nov 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    189
    Applicant Total
    14
    Review Days
    91

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Ai Ray Dental X-Ray Device
    K Number
    K222569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guilin Woodpecker Medical Instrument Co., Ltd.
    Date Received
    August 24, 2022
    Decision Date
    November 23, 2022
    Product Code
    EHD
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EHD Unit, X-Ray, Extraoral With Timer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EHD), ordered by most recent decision date.

    Portable Dental X-ray System Model PDX nova

    FDA 510(k)
    FDA Class 2 ·Dental

    NOMAD Pro 3

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental X-RAY Unit (AJX200)

    FDA 510(k)
    FDA Class 2 ·Dental

    Portable Dental X-ray Device (GT-1)

    FDA 510(k)
    FDA Class 2 ·Dental

    Diagnostic X-Ray Equipment Model POCT22

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Guilin Woodpecker Medical Instrument Co., Ltd.

    K Number Device Name
    K251438 Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
    K211358 Implanter incl. Accessories
    K221548 Dental Air Polishing Handpiece
    K210367 D-Laser Blue, D-Laser 16
    K203706 Dental Electric Motor
    K211531 Cordless Prophy System, Model: i-Polish
    K203615 Dental Scaler and Air Polisher
    K212080 Imaging Plate Scanner, i-Scan
    K203320 Endo Motor
    K181087 Apex Locator, DPEX III
    Search all 14 clearances from Guilin Woodpecker Medical Instrument Co., Ltd. →