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510(k) Data Aggregation

    K Number
    K151088
    Device Name
    DMRC Bulk Fill
    Manufacturer
    DANVILLE MATERIALS, LLC
    Date Cleared
    2015-08-28

    (127 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANVILLE MATERIALS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DMRC Bulk Fill is a dual-cure (auto-cure) with light-cure acceleration) polymer-based dental restoratives that when applied to dental surfaces pretreated with suitable primers or adhesives are use as the first incrual with posterior composites, for core build-ups; and for luting posts, crowns, veneers sead any application there light transmission may be inadequate
    Device Description
    DMRC Bulk Fill is a dual-cure (auto-cure) with light-cure acceleration) polymer-based dental restoratives
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    K Number
    K142886
    Device Name
    DMRC Self-Cure Bracket Adhesive One Step and Primer
    Manufacturer
    DANVILLE MATERIALS, LLC.
    Date Cleared
    2015-03-18

    (167 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANVILLE MATERIALS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a one step no-mix adhesive for direct bonding of orthodontic bracket to tooth structure
    Device Description
    The DMRC Self-Cure Bracket Adhesive One Step and Primer is a resin based adhesive designed for direct bonding of orthodontic brackets with no-mix step.
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    K Number
    K142881
    Device Name
    DMRC Dual Cure Orthodontic Band Cement
    Manufacturer
    DANVILLE MATERIALS, LLC.
    Date Cleared
    2015-02-13

    (134 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANVILLE MATERIALS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DMRC Dual Cure Orthodontic Band Cement is a dual-cure adhesive intended for use as an orthodontic band cement for bonding of orthodontic bands to enamel
    Device Description
    DMRC Dual Cure Orthodontic Band Cement is a resin based material containing a dual-cure adhesive for cementation of orthodontic bands. The DMRC Dual Cure Orthodontic Band Cement is a polymer based filling and restorative material; it contains a base and catalyst for dual curing process as orthodontic band cement.
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