BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Zeramex Dental Implant System

    Reg #: 3008388248 · FEI: 3008388248 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CeramTec Schweiz GmbH
    Registration Number
    3008388248
    FEI Number
    3008388248
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bodenaeckerstrasse 5
    City
    Spreitenbach Aargau
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K163043

    Owner / Operator

    Firm Name
    CeramTec Schweiz GmbH
    Operator Number
    10032409
    Address
    Bodenaeckerstrasse 5
    City
    Spreitenbach
    State
    Aargau
    Postal Code
    8957
    Country
    CH
    Correspondent
    Stefan Ruck

    US Agent

    Business Name
    ICON Clinical Research
    Contact Name
    Jamie Harris
    Address
    731 Arbor Way Ste 100
    City
    Blue Bell
    State
    PA
    ZIP
    19422
    Country
    US
    Email
    [email protected]
    Phone
    661 6459048

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    Zeramex Dental Implant System

    Establishment Types

    Manufacture Medical Device