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    FDA Registration Active 🇯🇵 Japan

    KURARAY NORITAKE DENTAL NIIGATA PLANT

    Reg #: 3002807420 · FEI: 3002807420 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    54
    Establishment Types
    1
    Classifications
    9

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    Registration Details

    Registration Name
    KURARAY NORITAKE DENTAL NIIGATA PLANT
    Registration Number
    3002807420
    FEI Number
    3002807420
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-28 KURASHIKI-CHO
    City
    TAINAI Niigata
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K033970

    Owner / Operator

    Firm Name
    KURARAY NORITAKE DENTAL INC.
    Operator Number
    8030414
    Address
    1621 SAKAZU
    City
    KURASHIKI
    State
    Okayama
    Postal Code
    710-0801
    Country
    JP
    Correspondent
    Satoshi - Yamaguchi

    US Agent

    Business Name
    KURARAY AMERICA, INC.
    Contact Name
    MANABU SUZUKI
    Address
    32 Old Slip, 7th Floor,
    City
    New York
    State
    NY
    ZIP
    10005
    Country
    US
    Email
    [email protected]
    Phone
    212 3563940

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE
    Cement, Dental EMA
    External Cleaning Solution PME
    Varnish, Cavity LBH
    Device, Caries Detection LFC
    Applicator, Resin KXR
    Syringe, Restorative And Impression Material EID
    Liner, Cavity, Calcium Hydroxide EJK

    Proprietary Names

    CLEARFIL PHOTO CORE PLT CLEARFIL SA PRIMER PANAVIA SA Cement Universal PANAVIA 21 CLEARFIL MAJESTY ES Flow CLEARFIL MAJESTY ES Flow Universal CLEARFIL Universal Bond Quick KATANA Cleaner CLEARFIL PHOTO BOND CLEARFIL LINER BOND 2V CLEARFIL MAJESTY Posterior CLEARFIL CERAMIC PRIMER PLUS CLEARFIL MAJESTY ES-2 PANAVIA V5 CLEARFIL DC CORE PLUS CARIES DETECTOR CLEARFIL TRI-S BOND PLUS CLEARFIL PORCELAIN BOND ACTIVATOR CLEARFIL SE Protect Applicator brush (endo<black>) Disposable brush tips (white) Applicator brush (superfine<white>) Applicator brush (fine<silver>) Disposable brush tips (black) ALLOY PRIMER K-ETCHANT Syringe CLEARFIL PHOTO CORE CLEARFIL AP-X PLT CLEARFIL DC CORE PLUS Guide tip (S) PANAVIA V5 Mixing tip PANAVIA SA Cement Universal Automix Mixing tip CLEARFIL DC CORE PLUS Mixing tip PANAVIA V5 Endo tip (S) PANAVIA SA Cement Universal Automix Endo tip (SS) CLEARFIL DC CORE PLUS Guide tip (L) CLEARFIL MAJESTY Flow CLEARFIL SE BOND CLEARFIL SE BOND Restorative Kit CLEARFIL ST OPAQUER TEETHMATE DESENSITIZER PANAVIA Veneer LC PANAVIA F 2 PANAVIA F 2 Complete Kit CLEARFIL DC Activator CLEARFIL Universal Bond Kit CLEARFIL Universal Bond CLEARFIL MAJESTY Posterior PLT K-ETCHANT GEL CLEARFIL Universal Bond Quick 2 CLEARFIL SE BOND 2 CLEARFIL MAJESTY IC CLEARFIL MAJESTY IC Bulk CLEARFIL MAJESTY IC Trial Kit CLEARFIL AP-X

    Establishment Types

    Manufacture Medical Device