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

    LIGHT-CURED ORTHODONTIC BAND CEMENT

    K Number: K001446 · Decision Jul 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    72
    Review Days
    74

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    Basic Information

    Device Name
    LIGHT-CURED ORTHODONTIC BAND CEMENT
    K Number
    K001446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scientific Pharmaceuticals, Inc.
    Date Received
    May 8, 2000
    Decision Date
    July 21, 2000
    Product Code
    DYH
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DYH Adhesive, Bracket And Tooth Conditioner, Resin

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