BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Replace Select Tapered PMC Implants

    Reg #: 2027971 · FEI: 1000125598 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NOBEL BIOCARE USA, LLC
    Registration Number
    2027971
    FEI Number
    1000125598
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    22715 Savi Ranch Parkway
    City
    YORBA LINDA
    State
    CA
    ZIP
    92887
    Country
    US

    Regulatory Submissions

    510(k) Number
    K023113

    Owner / Operator

    Firm Name
    Nobel Biocare Services AG
    Operator Number
    8030879
    Address
    Balz-Zimmermann-Strasse 7
    City
    Kloten
    State
    Zurich
    Postal Code
    8302
    Country
    CH
    Correspondent
    Valeria Barbarito

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    Replace Select Tapered PMC Implants Replace Select Tapered Replace Select TC Implants

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)