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510(k) Data Aggregation

    K Number
    K152652
    Device Name
    PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
    Date Cleared
    2016-04-05

    (202 days)

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

    GAIA DENTAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PackFil RMGI Restorative Cement is indicated for filling and restoration of tooth of following typical applications: - Primary teeth restorations; - Class I restorations: - Class III and V restorations: - Transitional restorations; - Base liners or laminated/sandwich restorations; - Selective core build-ups (>50% coronal tooth intact);
    Device Description
    PackFil Resin Modified Glass Ionomer (RMGI) Restorative Cement is used by dental professionals and intended for filling and restoration of teeth. The subject device possesses triple curing mechanisms of conventional acid-base glass ionomer reaction. methacrylate resin chemical curing and light curable on demand. It is a tooth colored, radiopaque (equivalent of 2.5 mm of aluminum), two-part paste/paste resin modified glass ionomer restorative cement material, with each part is packaged separately when not in use. PackFil RMGI provides the common benefits typical of conventional glass ionomer materials, with the feature of being packable after the two parts mixed together. The filler content of this system is primarily a combination of traditional silane treated barium-boro-silicate glass filler and radiopaque acid reactive fluoroaluminosilicate glass filler having a hybrid particle size range from about 0.01 up to about 5 micrometers while the resin system has a combination of aqueous polyacrylic acid copolymer, phosphate and other polymerizable methacrylate resins.
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