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

    ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM

    K Number: K040748 · Decision Jun 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    183
    Applicant Total
    6
    Review Days
    71

    Basic Information

    Device Name
    ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM
    K Number
    K040748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TAKARA BELMONT USA, INC.
    Date Received
    March 23, 2004
    Decision Date
    June 2, 2004
    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

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