BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    EDELWEISS DENTISTRY PRODUCTS GMBH

    Reg #: 3009117991 · FEI: 3009117991 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    198
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    EDELWEISS DENTISTRY PRODUCTS GMBH
    Registration Number
    3009117991
    FEI Number
    3009117991
    Status
    Active
    Expiry Year
    2026
    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
    Drill, Dental, Intraoral DZA
    Post, Root Canal ELR
    Material, Tooth Shade, Resin EBF
    Crown, Preformed ELZ

    Proprietary Names

    edelweiss CAD/CAM C-BLOCK A3 (10/12/16) Ceramir CAD/CAM T-BLOCK Universal Enamel edelweiss CAD/CAM i-BLOCK (øS) A1 Ceramir CAD/CAM i-BLOCK (øS) A0 Ceramir CAD/CAM i-BLOCK (øL) A1 Ceramir CAD/CAM i-BLOCK (øS) A1 edelweiss CAD/CAM i-BLOCK (øS) A0 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) Ceramir CAD/CAM i-BLOCK (øL) A2 edelweiss CAD/CAM C-BLOCK A2 (10/12/16) edelweiss CAD/CAM C-BLOCK A3 (12/14/18) edelweiss CAD/CAM i-BLOCK (øL) A2 Ceramir CAD/CAM i-BLOCK (øS) A3 edelweiss CAD/CAM i-BLOCK (øL) Universal Enamel Ceramir CAD/CAM i-BLOCK (øL) A0 edelweiss CAD/CAM i-BLOCK (øL) A3 edelweiss CAD/CAM i-BLOCK (øS) A2 Ceramir CAD/CAM C-BLOCK A2 edelweiss CAD/CAM C-BLOCK A0 (10/12/16) edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16) Ceramir CAD/CAM i-BLOCK (øL) A3 edelweiss CAD/CAM i-BLOCK (øL) A0 edelweiss CAD/CAM C-BLOCK A0 (12/14/18) edelweiss CAD/CAM C-BLOCK A2 (12/14/18) 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 i-BLOCK (øS) A2 Ceramir CAD/CAM i-BLOCK (øL) Universal Enamel Ceramir CAD/CAM C-BLOCK A0 edelweiss CAD/CAM i-BLOCK (øS) A3 edelweiss CAD/CAM i-BLOCK (øL) A1 Ceramir CAD/CAM C-BLOCK A3 edelweiss Pediatric Crown 54/B Size M edelweiss Pediatric Crown 72/N Size S edelweiss Pediatric Crown 62/G Size L edelweiss Pediatric Crown 52/D Size M edelweiss Pediatric Crown 81/P Size S edelweiss Pediatric Crown 75/K Size L edelweiss Pediatric Crown 55/A Size L edelweiss Pediatric Crown 53/C Size L edelweiss Pediatric Crown 65/J Size M edelweiss Pediatric Crown 64/I Size S edelweiss Pediatric Crown 54/B Size L edelweiss Pediatric Crown 74/L Size S edelweiss Pediatric Crown 63/H Size M edelweiss Pediatric Crown 83/R Size L edelweiss Pediatric Crown 81/P Size M edelweiss Pediatric Crown 71/O Size S edelweiss Pediatric Crown 85/T Size S edelweiss Pediatric Crown 54/B Size S edelweiss Pediatric Crown 62/G Size M edelweiss Pediatric Crown 71/O Size M edelweiss Pediatric Crown 74/L Size M edelweiss Pediatric Crown 82/Q Size S edelweiss Pediatric Crown 64/I Size L edelweiss Pediatric Crown 83/R Size M edelweiss Pediatric Crown 75/K Size S edelweiss Pediatric Crown 61/F Size S edelweiss Pediatric Crown 61/F Size M edelweiss Pediatric Crown 73/M Size M edelweiss Pediatric Crown 81/P Size L edelweiss Pediatric Crown 53/C Size S edelweiss Pediatric Crown 51/E Size M edelweiss Pediatric Crown 62/G Size S edelweiss Pediatric Crown 61/F Size L edelweiss Pediatric Crown 73/M Size S edelweiss Pediatric Crown 63/H Size S edelweiss Pediatric Crown 52/D Size L edelweiss Pediatric Crown 63/H Size L edelweiss Pediatric Crown 55/A Size M edelweiss Pediatric Crown 82/Q Size M edelweiss Pediatric Crown 84/S Size S edelweiss Pediatric Crown 82/Q Size L edelweiss Pediatric Crown 52/D Size S edelweiss Pediatric Crown 72/N Size M edelweiss Pediatric Crown Toolbox edelweiss Pediatric Crown 74/L Size L edelweiss Pediatric Crown 55/A Size S edelweiss Pediatric Crown 84/S Size L edelweiss Pediatric Crown 73/M Size L edelweiss Pediatric Crown 85/T Size L edelweiss Pediatric Crown 65/J Size S edelweiss Pediatric Crown 85/T Size M edelweiss Pediatric Crown 53/C Size M edelweiss Pediatric Crown 65/J Size L edelweiss Pediatric Crown 84/S Size M edelweiss Pediatric Crown 72/N Size L edelweiss Pediatric Crown 51/E Size L edelweiss Pediatric Crown 83/R Size S edelweiss Pediatric Crown 64/I Size M edelweiss Pediatric Crown 71/O Size L edelweiss Pediatric Crown 75/K Size M edelweiss Pediatric Crown 51/E Size S Ceramir Pediatric Crown 61/F Size XL Ceramir Pediatric Crown 64/I Size M Ceramir Pediatric Crown 72/N Size M Ceramir Pediatric Crown 73/M Size S edelweiss Pediatric Crown 82/Q Size XL edelweiss Pediatric Crown 75/K Size XL Ceramir Pediatric Crown 75/K Size S Ceramir Pediatric Crown 53/C Size S Ceramir Pediatric Crown 75/K Size XL Ceramir Pediatric Crown 85/T Size M Ceramir Pediatric Crown 53/C Size M Ceramir Pediatric Crown 74/L Size XL Ceramir Pediatric Crown 51/E Size M Ceramir Pediatric Crown 74/L Size M Ceramir Pediatric Crown 53/C Size L Ceramir Pediatric Crown 72/N Size S edelweiss Pediatric Crown 51/E Size XL Ceramir Pediatric Crown 54/B Size S edelweiss Pediatric Crown 71/O Size XL Ceramir Pediatric Crown 62/G Size L Ceramir Pediatric Crown 72/N Size XL Ceramir Pediatric Crown 63/H Size M Ceramir Pediatric Crown 65/J Size XL Ceramir Pediatric Crown 64/I Size L edelweiss Pediatric Crown 62/G Size XL Ceramir Pediatric Crown 81/P Size XL Ceramir Pediatric Crown 64/I Size XL edelweiss Pediatric Crown 65/J Size XL Ceramir Pediatric Crown 61/F Size S Ceramir Pediatric Crown 72/N Size L Ceramir Pediatric Crown 64/I Size S Ceramir Pediatric Crown 54/B Size XL Ceramir Pediatric Crown 53/C Size XL Ceramir Pediatric Crown 83/R Size L Ceramir Pediatric Crown 82/Q Size XL Ceramir Pediatric Crown Start Kit Small Ceramir Pediatric Crown 71/O Size M Ceramir Pediatric Crown 65/J Size M edelweiss Pediatric Crown 63/H Size XL Ceramir Pediatric Crown 62/G Size S Ceramir Pediatric Crown 82/Q Size S Ceramir Pediatric Crown 62/G Size XL Ceramir Pediatric Crown 74/L Size S Ceramir Pediatric Crown 55/A Size M Ceramir Pediatric Crown 81/P Size L edelweiss Pedatric Crown 85/T Size XL Ceramir Pediatric Crown 85/T Size L Ceramir Pediatric Crown 84/S Size L Ceramir Pediatric Crown 81/P Size S Ceramir Pediatric Crown 83/R Size M edelweiss Pediatric Crown 64/I Size XL Ceramir Pediatric Crown 71/O Size L Ceramir Pediatric Crown 63/H Size XL Ceramir Pediatric Crown 74/L Size L edelweiss Pediatric Crown 74/L Size XL Ceramir Pediatric Crown 52/D Size S Ceramir Pediatric Crown 85/T Size S Ceramir Pediatric Crown 85/T Size XL Ceramir Pediatric Crown 83/R Size XL edelweiss Pediatric Crown 52/D Size XL Ceramir Pediatric Crown 75/K Size M Ceramir Pediatric Crown 84/S Size XL Ceramir Pediatric Crown 71/O Size S edelweiss Pediatric Crown 53/C Size XL Ceramir Pediatric Crown 75/K Size L edelweiss Pediatric Crown 84/S Size XL Ceramir Pediatric Crown 71/O Size XL edelweiss Pediatric Crown 72/N Size XL Ceramir Pediatric Crown 62/G Size M Ceramir Pediatric Crown 73/M Size M Ceramir Pediatric Crown 52/D Size M Ceramir Pediatric Crown 51/E Size XL edelweiss Pediatric Crown 73/M Size XL Ceramir Pediatric Crown 52/D Size L edelweiss Pediatric Crown 54/B Size XL Ceramir Pediatric Crown 54/B Size M Ceramir Pediatric Crown 73/M Size L edelweiss Pediatric Crown 83/R Size XL Ceramir Pediatric Crown 73/M Size XL Ceramir Pediatric Crown 55/A Size L Ceramir Pediatric Crown 51/E Size L Ceramir Pediatric Crown 52/D Size XL Ceramir Pediatric Crown 84/S Size S Ceramir Pediatric Crown 82/Q Size L Ceramir Pediatric Crown 61/F Size L Ceramir Pediatric Crown 63/H Size L Ceramir Pediatric Crown Start Kit Complete edelweiss Pediatric Crown 61/F Size XL Ceramir Pediatric Crown 63/H Size S Ceramir Pediatric Crown 51/E Size S edelweiss Pediatric Crown 81/P Size XL Ceramir Pediatric Crown 81/P Size M Ceramir Pediatric Crown 82/Q Size M Ceramir Pediatric Crown 84/S Size M Ceramir Pediatric Crown 55/A Size S Ceramir Pediatric Crown 65/J Size L Ceramir Pediatric Crown 83/R Size S Ceramir Pediatric Crown 61/F Size M Ceramir Pediatric Crown 54/B Size L Ceramir Pediatric Crown 65/J Size S Ceramir Pediatric Crown 55/A Size XL edelweiss Pediatric Crown 55/A Size XL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device