BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    etkon GMBH

    Reg #: 3005106408 · FEI: 3005106408 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    etkon GMBH
    Registration Number
    3005106408
    FEI Number
    3005106408
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LOCHHAMER SCHLAG 6
    City
    GRAEFELFING, BAVARIA
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K093113

    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
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    Straumann CARES CS2 Scanner CARES Abutment S300W Straumann CARES Visual Chairside DWOS Straumann CARES Visual AS260 ST200E ST 300E DI-1 Smart Design SIRIOS AS200E

    Establishment Types

    Manufacture Medical Device