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510(k) Data Aggregation

    K Number
    K131036
    Device Name
    YAMAHACHI DENTURE BASE RESINS
    Date Cleared
    2013-07-12

    (88 days)

    Product Code
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    YAMAHACHI DENTAL MANUFACTURING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Yamahachi Denture Base Resins is intended for fabrication or repair of the denture base.
    Device Description
    Yamahachi Denture Base Resins is supplied in powder and liquid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) beads with small quantities of initiator and color pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator. To fabricate the denture base, the powder and liquid materials are mixed together and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures either through heat application (water bath, rapid immersion, or microwave oven) or a self-curing process (pressure vessel or via quick-setting). While heat-cure resins are generally used to fabricate denture bases, self-cure acrylics are most often indicated for repair and relining of the dentures. The subject device includes three heat-cure resins (Basis, Basis HI, and Basis Twin Cure) and two self-cure resins (Basis Flow and Re-Fine Bright).
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