BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE

    K Number: K896024 · Decision Jan 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    41
    Applicant Total
    1
    Review Days
    98

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    Basic Information

    Device Name
    MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
    K Number
    K896024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1810
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Mdt Diagnostic Co.
    Date Received
    October 16, 1989
    Decision Date
    January 22, 1990
    Product Code
    EAP
    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
    EAP Unit, X-Ray, Intraoral

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