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510(k) Data Aggregation

    K Number
    K142446
    Device Name
    Fixtemp Cement
    Manufacturer
    EXACTA DENTAL DIRECT, INC
    Date Cleared
    2015-06-04

    (275 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXACTA DENTAL DIRECT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FixTemp ™ Cement is a dental luting agent indicated for: - temporary cementation of provisional crowns and bridges, - cementing of semi-permanent implants.
    Device Description
    The Fixtemp Cement is designed as a luting cement for temporary dental applications. This dental cement having the active ingredients of zinc oxide does not include Eugenol. This lack of Eugenol does not reduce structural properties but allows a choice among healthcare professionals where Eugenol can cause objectionable results.
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    K Number
    K102917
    Device Name
    FIXTEMP C&B
    Manufacturer
    EXACTA DENTAL DIRECT, INC
    Date Cleared
    2011-06-17

    (259 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXACTA DENTAL DIRECT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FixTemp C&B ™ is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges. The intended use of the FixTemp C&B "" is to form short and long term dental provisional prosthetics.
    Device Description
    The FixTemp C&B *** is a Class II (nonexempt) device that is ideal suited as a dental acrylic to fabricate temporary crown and bridges. FixTemp C&B "" provisional material is a two component, catalyst and base, material dispensed and mixed by a industry standard cartridge/static mixing tip combination. FixTemp C&B "" is intended for . use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. FixTemp C&B "" contains methacrylate components and is radiopaque for easy radiographic identification. The scientific concept on which this device is based is the principle that ethoxylated Bis-GMA is a multifunctional acrylates and inorganic fillers as silinated barium glass and silinated silicic acid to form a suitable structure for a short and long term crown and bridge temporaries. This device functions by providing a dental material to short and long term dental provisional prosthetics.
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