BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    etkon GMBH

    Reg #: 3011221537 · FEI: 3011221537 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    44
    Establishment Types
    1
    Classifications
    8

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    Registration Details

    Registration Name
    etkon GMBH
    Registration Number
    3011221537
    FEI Number
    3011221537
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Koburger Strasse 45
    City
    Markkleeberg Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K101465

    Owner / Operator

    Firm Name
    INSTITUT STRAUMANN AG
    Operator Number
    9005052
    Address
    PETER MERIAN-WEG 12
    City
    BASEL
    State
    CH-NOTA
    Postal Code
    CH-4002
    Country
    CH
    Correspondent
    Andreas Petermann

    US Agent

    Business Name
    Straumann USA, LLC
    Contact Name
    Jennifer M Jackson
    Address
    60 Minuteman Rd
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 7472509

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Crown And Bridge, Temporary, Resin EBG
    Powder, Porcelain EIH
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Implant, Endosseous, Root-Form DZE
    Alloy, Metal, Base EJH
    Material, Tooth Shade, Resin EBF
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Straumann CARES Screw-Retained Bridge and Dolder Bar STRAUMANN DENTAL IMPLANT SYSTEM polycon ae restoration Strauamnn CARES Dolder Bar Titanium Straumann CARES Screw-retained Bridge Titanium Porcelain powder Straumann Variobase for Crown AS Straumann CARES CS2 Scanner CARES Abutment SRBB Bone Level n!ce® for Planmill Straumann® CARES® Golden Ti/TiN Abutments Roxolid BLX Implants NC Variobase™ Abutments, with screw, D 3.8mm, H 3.5mm, TAN NC Variobase®, for crown, with screw, D 3.8mm, H 5.5mm, TAN NNC Variobase™ Abutments, with screw, D 3.9mm, H 3.75mm, TAN RC Variobase®, for crown, with screw, D 4.5mm, H 5.5mm, TAN WN Variobase™ Abutments, with screw, D 7mm, H 4.5mm, TAN RC Variobase™ Abutments, with screw, D 4.5mm, 3.5mm, TAN WN Variobase®, for crown, with screw, D 7mm, H 6.5mm, TAN RN Variobase™ Abutments, with screw, D 55mm, H 4mm, TAN NNC Variobase®, for crown, with screw, D 3.9mm, H 5.75mm, TAN RN Variobase®, for crown, with screw, D 55mm, H 6mm, TAN n!ce Crown n!ce Inlay n!ce Partial Crown n!ce Veneer n!ce Onlay Straumann CARES Abutments Straumann Custom Abutment AS ticon and coron restorations polyamide restoration Dental Implant Accesories Straumann Variobase Abutments zerion and glass ceramic restorations Straumann Dental Implant System zerion HT elements NNC Variobase Abutment, with screw, D 55mm, H 4mm, TAN NC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN RN Variobase Abutment, with screw, D 55mm, H 4mm, TAN RC Variobase Abutment, with screw, D 4.5mm, 3.5mm, TAN WN Variobase Abutment, with screw, D 7mm, H 4.5mm, TAN CARES TAN Abutment Straumann CARES TAN Abutment

    Establishment Types

    Manufacture Medical Device