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510(k) Data Aggregation

    K Number
    K080687
    Device Name
    SMARTBURS
    Manufacturer
    S.S. WHITE BURS, INC.
    Date Cleared
    2008-06-20

    (101 days)

    Product Code
    EJL
    Regulation Number
    872.3240
    Why did this record match?
    Applicant Name (Manufacturer) :

    S.S. WHITE BURS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    After primary access using another instrument, Smartburs is intended to selectively remove decayed dentin, without removal of healthy dentin from tooth surfaces. Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum, or healthy dentin.
    Device Description
    Smartburs
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