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510(k) Data Aggregation

    K Number
    K161042
    Device Name
    CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
    Manufacturer
    Kuraray Noritake Dental, Inc.
    Date Cleared
    2016-10-25

    (195 days)

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

    Kuraray Noritake Dental, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    [1] Direct restorations using light-cured composite resin [2] Cavity sealing as a pretreatment for indirect restorations [3] Treatment of exposed root surfaces [4] Treatment of hypersensitive teeth [5] Intraoral repairs of fractured restorations [6] Post cementation and core build-ups [7] Cementation of indirect restorations
    Device Description
    Not Found
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    K Number
    K153476
    Device Name
    KATANA AVENCIA Block
    Manufacturer
    Kuraray Noritake Dental, Inc.
    Date Cleared
    2016-08-23

    (265 days)

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

    Kuraray Noritake Dental, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of inlays, onlays, veneers and full contour crown restorations, using a dental CAD/CAM system.
    Device Description
    Not Found
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    K Number
    K150704
    Device Name
    PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
    Manufacturer
    KURARAY NORITAKE DENTAL, INC.
    Date Cleared
    2015-08-21

    (156 days)

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

    KURARAY NORITAKE DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    [1] Cementation of crowns, bridges, inlays and onlays [2] Cementation of veneers [3] Cementation of adhesion bridges and splints [4] Cementation of prosthetic restorations on implant abutments and frames [5] Cementation of posts and cores [6] Amalgam bonding
    Device Description
    The subject device is an adhesive resin cement system. It consists of the cement paste (Paste), Try-in Paste, Tooth Primer, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe. The Paste is a dual-cure (light- and/or self-cure), fluoride-releasing, radiopaque resin cement for ceramics (lithium disilicate, zirconia, etc.), hybrid ceramics, composite resins, and metal restorations. It is supplied in an automix delivery system which mixes equal amounts of two components. It is available in the following 5 shades; Universal (A2), Clear, Brown (A4), White, and Opaque. The Opaque shade should be self-cured for final curing due to its strong opacity. The Try-in Paste is a shade matching material which has approximate color and transparency as the hardened mixture of Paste. The Tooth Primer is a self-etching primer to tooth structures that accelerates the polymerization of the Paste.
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    K Number
    K143439
    Device Name
    KATANA Zirconia
    Manufacturer
    KURARAY NORITAKE DENTAL, INC.
    Date Cleared
    2015-02-27

    (87 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KURARAY NORITAKE DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KATANA Zirconia is used for the fabrication of the all-ceramic restorations (frameworks, FCZ crowns, FCZ bridges, inlays, onlays and veneers).
    Device Description
    Not Found
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    K Number
    K142623
    Device Name
    PANAVIA SA Cement Plus Handmix
    Manufacturer
    KURARAY NORITAKE DENTAL, INC.
    Date Cleared
    2015-02-26

    (163 days)

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

    KURARAY NORITAKE DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    [1] Cementation of crowns, bridges, inlays and onlays [2] Cementation of prosthetic restorations on implant abutments and frames [3] Cementation of adhesion bridges and splints [4] Cementation of posts and cores [5] Amalgam bonding
    Device Description
    The subject device is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations.
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