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510(k) Data Aggregation

    K Number
    K121880
    Device Name
    DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2012-09-25

    (89 days)

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

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DMRC Nanoflow and DMRC Nanocomposite are designed for use in all classes of cavities. DMRC Nanoflow is a low viscosity composite and DMRC Nanocomposite is a universal viscosity composite.
    Device Description
    DMRC Nanoflow and DMRC Nanocomposite
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    K Number
    K111876
    Device Name
    Z BOND, PRELUDE ONE
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2011-09-21

    (82 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Z Bond and Prelude One are a Primer and adhesive used for: - Conditioning of zirconia, alumina, and metal definitive restorations prior to cementation, . e.g., crowns, posts, inlays, and onlays. - Adhesive repair of defects in zirconia, alumina, metal and composite restorations . currently affixed to a patient's dentition. - . Adhesive for bonding composites and other dental restorative materials to enamel or dentin.
    Device Description
    Not Found
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    K Number
    K102753
    Device Name
    TURBO TEMP 3
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2011-02-04

    (134 days)

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

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.
    Device Description
    Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.
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    K Number
    K092912
    Device Name
    STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2009-12-16

    (85 days)

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

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StarFill 2B HV and LV are 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 indicated for use as the first increment under posterior composites; for core buildups; and for luting posts, crowns, veneers and any application where light transmission may be inadequate.
    Device Description
    dual-cure (auto-cure with light-cure acceleration) polymer-based dental restoratives
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    K Number
    K092319
    Device Name
    STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2009-09-16

    (43 days)

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

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an additional-cure viny| polysiloxane dental impression material that is used for all crown and bridges, edentulous and Implant techniques.
    Device Description
    Not Found
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    K Number
    K090106
    Device Name
    PRELUDE ONE
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2009-03-31

    (89 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prelude One is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges.
    Device Description
    Prelude One is a dental bonding agent used to restore all classes of cavities
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    K Number
    K040952
    Device Name
    PRELUDE
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2004-06-29

    (78 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges. When used with Prelude Activator, Prelude may also be used with self or dual cure materials.
    Device Description
    Prelude is a dental bonding agent used to restore all classes of cavities.
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    K Number
    K033215
    Device Name
    PREPAIR
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2004-01-09

    (98 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
    Device Description
    The PrepAir is a dental airbrush using aluminum oxide to prepare all classes of cavity prior to restoration.
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    K Number
    K020760
    Device Name
    STARFLOW HV
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2002-05-03

    (57 days)

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

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Starflow HV is intended for use for the restoration of Class III, Class IV, and Class V cavities, small Class I cavities not in occlusion, repair of enamel defects, repair of porcelain restorations, minor occusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for seramic/composite veneers, incisal abrasions, and core build-ups.
    Device Description
    Starflow HV is a light-cured, hybrid dental retorative which incorporates BIS/GMA resin along with Barium aluminosilicate glass filler (64% by wt) to yield a flowable dental restorative.
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    K Number
    K012354
    Device Name
    SNOWPOST, SNOWLIGHT
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2001-10-10

    (77 days)

    Product Code
    ELR
    Regulation Number
    872.3810
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANVILLE MATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Snowpost & Snowlight posts are indicated for use wherever root canal posts are required Showpost & Showingin posts are mellor and/or where known metal allergies are of concern.
    Device Description
    Not Found
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