BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KURARAY NORITAKE DENTAL INC. MIYOSHI PLANT

    Reg #: 9614705 · FEI: 3009523116 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    KURARAY NORITAKE DENTAL INC. MIYOSHI PLANT
    Registration Number
    9614705
    FEI Number
    3009523116
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    300 HIGASHIYAMA, MIYOSHI-CHO
    City
    MIYOSHI Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K033049

    Owner / Operator

    Firm Name
    KURARAY NORITAKE DENTAL INC.
    Operator Number
    10031961
    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
    Powder, Porcelain EIH
    Abutment, Implant, Dental, Endosseous NHA
    Wheel, Polishing Agent EJQ

    Proprietary Names

    CZR PRESS Esthetic White Kit CZR PRESS CZR PRESS LF CZR PRESS Trial-H Kit EX-3 PRESS TRIAL KIT H2 EX-3 PRESS TRIAL KIT L1 EX-3 PRESS EX-3 PRESS LF ESTHETIC WHITE KIT EX-3 PRESS LF ESTHETIC WHITE LAYERING KIT EX-3 PRESS LF EX-3 PRESS TRIAL KIT L2 EX-3 PRESS TRIAL KIT H1 KATANA Zirconia Noritake Super Porcelain EX-3 CERABIEN MiLai Noritake Super Porcelain Ti-22 CERABIEN KATANA Zirconia ONE For IMPLANT NORITAKE DENTAL SUPPLY CO. LTD CERABIEN ZR CERABIEN ZR TRIAL KIT SS NV1120 CERABIEN ZR SS ESTHETIC WHITE KIT CERABIEN ZR SS BASIC FULL KIT CERABIEN ZR VALUE SHADE FULL KIT CERABIEN ZR TRIAL KIT SS A2 Noritake Super Porcelain EX-3 n COLOR FULL KIT PST Noritake Super Porcelain EX-3 NORITAKE ORIGINAL SHADE KIT Noritake Super Porcelain EX-3 FULL KIT PST SCREENING PORCELAIN Noritake Super Porcelain EX-3 TRIAL KIT UP nA2 Noritake Super Porcelain EX-3 Value Shade FULL KIT Noritake Super Porcelain EX-3 TRIAL KIT NV1120 Noritake Super Porcelain EX-3 ESTHETIC WHITE KIT Noritake Super Porcelain EX-3 n COLOR INTRO KIT Noritake Super Porcelain EX-3 n COLOR INTRO POBA KIT Esthetic Colorant KATANA Zirconia Block KATANA Zirconia ONE CZR PRESS Trial-L Kit CZR PRESS LF ESTHETIC WHITE LAYERING KIT

    Establishment Types

    Manufacture Medical Device