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510(k) Data Aggregation

    K Number
    K981036
    Device Name
    SMARTBOND
    Manufacturer
    GAC INTL., INC.
    Date Cleared
    1999-04-05

    (382 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAC INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    the bonding Adhesive to be used as an orthodontic bonding agent, for the bonding of orthodontic braces on the tooth (brackets, tubes and which ever) for a limited period of time.
    Device Description
    Not Found
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