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510(k) Data Aggregation

    K Number
    K132599
    Device Name
    SMILEBOND SYSTEM
    Date Cleared
    2014-02-25

    (189 days)

    Product Code
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLENNIUM COMPANY LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SmileBond Systems Fast Bite Registration material is used for making impressions of the tech and gums of patients requiring enhancement of the smile and for bite alignment.
    Device Description
    SmileBond System is a patented process for the delivery of dental bonding composites. The SmileBond process is indicated for both cosmetic enhancement of the smile, and functional improvement of the bite (or chewing system). Fast-Set Bite Registration is a silicone impression material intended to be placed on an impression tray to reproduce the structures of the teeth and gums of patients requiring the enhancement of the smile and for bite alignment. The impression material is intended to be applied via a dual barrel cartridge system into an impression tray. The clear impression material is used in the lab to make an accurate impression of the final wax up. Once the impression material is set and slightly modified it is taken to the mouth for use in the transfer bonding process.
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