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    FDA Registration Active 🇦🇹 Austria

    edelweiss CAD/CAM C-BLOCK A0 (12/14/18)

    Reg #: 3009117991 · FEI: 3009117991 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EDELWEISS DENTISTRY PRODUCTS GMBH
    Registration Number
    3009117991
    FEI Number
    3009117991
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Dammstrasse 68
    City
    Wolfurt Vorarlberg
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K241131

    Owner / Operator

    Firm Name
    edelweiss dentistry products gmbh
    Operator Number
    10036346
    Address
    Dammstrasse 68
    City
    Wolfurt
    State
    Vorarlberg
    Postal Code
    6922
    Country
    AT

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    edelweiss CAD/CAM C-BLOCK A0 (12/14/18) edelweiss CAD/CAM C-BLOCK A2 (12/14/18) edelweiss CAD/CAM C-BLOCK A0 (10/12/16) edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16) Ceramir CAD/CAM C-BLOCK A1 edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18) edelweiss CAD/CAM C-BLOCK A1 (10/12/16) edelweiss CAD/CAM i-BLOCK (øS) A3 edelweiss CAD/CAM i-BLOCK (øS) A1 Ceramir CAD/CAM i-BLOCK (øS) A0 edelweiss CAD/CAM i-BLOCK (øL) A3 edelweiss CAD/CAM i-BLOCK (øS) A2 edelweiss CAD/CAM C-BLOCK A3 (10/12/16) Ceramir CAD/CAM i-BLOCK (øS) A1 Ceramir CAD/CAM i-BLOCK (øL) A3 edelweiss CAD/CAM C-BLOCK A1 (12/14/18) Ceramir CAD/CAM i-BLOCK (øS) Universal Enamel edelweiss CAD/CAM i-BLOCK (øS) Universal Enamel Ceramir CAD/CAM C-BLOCK A2 Ceramir CAD/CAM T-BLOCK Universal Enamel edelweiss CAD/CAM i-BLOCK (øL) Universal Enamel Ceramir CAD/CAM i-BLOCK (øL) Universal Enamel Ceramir CAD/CAM C-BLOCK A0 edelweiss CAD/CAM C-BLOCK A3 (12/14/18) edelweiss CAD/CAM i-BLOCK (øL) A2 Ceramir CAD/CAM i-BLOCK (øL) A1 Ceramir CAD/CAM i-BLOCK (øS) A2 Ceramir CAD/CAM i-BLOCK (øS) A3 edelweiss CAD/CAM C-BLOCK A2 (10/12/16) edelweiss CAD/CAM i-BLOCK (øL) A0 Ceramir CAD/CAM i-BLOCK (øL) A2 edelweiss CAD/CAM i-BLOCK (øL) A1 Ceramir CAD/CAM C-BLOCK A3 edelweiss CAD/CAM i-BLOCK (øS) A0 Ceramir CAD/CAM i-BLOCK (øL) A0

    Establishment Types

    Manufacture Medical Device