BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    LayZir Disc

    Reg #: 3012867029 · FEI: 3012867029 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Orbray Co LTD
    Registration Number
    3012867029
    FEI Number
    3012867029
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-8-22 Shinden Adachi Ku
    City
    Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K160203

    Owner / Operator

    Firm Name
    Orbray Co., Ltd.
    Operator Number
    10053339
    Address
    3-8-22 Shinden Adachi Ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    1238511
    Country
    JP
    Correspondent
    Arvilla Combs

    US Agent

    Business Name
    M Squared Associates/a PPG Company
    Contact Name
    Cherita James
    Address
    1129 20th St NW, Suite 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    347 9540624

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    LayZir Disc Zirconia Disc SHOFU DISK ZR Lucent Supra

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility