BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Zivino

    Reg #: 3013513796 · FEI: 3013513796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Orbray Co., Ltd.
    Registration Number
    3013513796
    FEI Number
    3013513796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12-1 Kamisakurazawa, Sotonome
    City
    Yokote-shi Akita
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K160203

    Owner / Operator

    Firm Name
    Orbray Co Ltd
    Operator Number
    10053336
    Address
    12-1 Kamisakurazawa, Sotonome
    City
    Yokote-shi
    State
    Akita
    Postal Code
    0130053
    Country
    JP
    Correspondent
    Shigeki Sato

    US Agent

    Business Name
    M2/PPG
    Contact Name
    Cherita James
    Address
    1129 20th St Nw Ste 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    202 8411075

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    Zivino LayZir Disc Zirconia Disc SHOFU DISK ZR Lucent Supra

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device