BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    GC Initial Zirconia Disk HT

    Reg #: 3005974404 · FEI: 3005974404 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Klema Dentalprodukte GMBH
    Registration Number
    3005974404
    FEI Number
    3005974404
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Koblacherstrasse 3A
    City
    Meiningen Vorarlberg
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K082740

    Owner / Operator

    Firm Name
    GC America Inc.
    Operator Number
    8030268
    Address
    3737 W. 127th Street
    City
    Alsip
    State
    IL
    Postal Code
    60803
    Country
    US
    Correspondent
    Futoshi Fusejima

    US Agent

    Business Name
    GC America Inc.
    Contact Name
    Futoshi Fusejima
    Address
    3737 W 127th St
    City
    Alsip
    State
    IL
    ZIP
    60803
    Country
    US
    Email
    [email protected]
    Phone
    708 9263050

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    GC Initial Zirconia Disk HT GC Initial Zirconia Disk ST GC Aadva Zr Disk GC Initial ZR Disk ML Elite

    Establishment Types

    Manufacture Medical Device