BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Klema Dentalprodukte GMBH

    Reg #: 3005974404 · FEI: 3005974404 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    32
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Klema Dentalprodukte GMBH
    Registration Number
    3005974404
    FEI Number
    3005974404
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Koblacherstrasse 3A
    City
    Meiningen Vorarlberg
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K152274

    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
    Teeth, Porcelain ELL
    Agent, Tooth Bonding, Resin KLE
    Denture, Plastic, Teeth ELM

    Proprietary Names

    MSCB-001 Initial Lustre Pastes NF Initial IQ Initial LiSi Initial PC Initial Initial TI Initial Spectrum Stains Initial Lustre Paste One Initial IQ SQIN Creation Creation CC Creation Magic Colour Creation ZI-CT, ZI-F Lisi PressVest Creation LS Initial One Initial Brush WILLI GELLER CREATION ZI PORCELAIN CREATION CP-ZI PORCELAIN GC Initial Zirconia Disk ST GC Initial Zirconia Disk HT GC Aadva Zr Disk GC Initial ZR Disk ML Elite WILLI GELLER CREATION PORCELAIN WILLI GELLER CREATION CP PORCELAIN WILLI GELLER CREATION II PORCELAIN Aadva Zr Coloring Liquid WILLI GELLER CREATION AND LF PORCELAIN METALPRIMER II WILLI GELLER CREATION & AV PORCELAIN WILLI GELLER CREAPEARL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device