BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    CARIES DETECTOR

    Reg #: 3002807420 · FEI: 3002807420 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KURARAY NORITAKE DENTAL NIIGATA PLANT
    Registration Number
    3002807420
    FEI Number
    3002807420
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-28 KURASHIKI-CHO
    City
    TAINAI Niigata
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K012733

    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
    Device, Caries Detection LFC

    Proprietary Names

    CARIES DETECTOR

    Establishment Types

    Manufacture Medical Device