BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    OsseoShaper 2

    Reg #: 3006540014 · FEI: 3006540014 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    NOBEL BIOCARE DISTRIBUTION CENTER BV
    Registration Number
    3006540014
    FEI Number
    3006540014
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Popeweg 72
    City
    Venlo Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K211109

    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
    Abutment, Implant, Dental, Endosseous NHA
    Non-Irrigation Endosseous Dental Implant Drill Bits QRQ
    Dental Abutment Design Software For Dental Laboratory PNP
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    OsseoShaper 2 Nobel Biocare N1 TiUltra Implants Universal Abutment Trioval Conical Connection OsseoShaper 1 Temporary Abutment N1 Trioval Conical Connection N1 Base Trioval Conical Connection Universal Abutment N1 Base Nobel Biocare N1 Cover Screws Clinical Screw Multi-unit Abutment N1 Trioval Conical Connection Clinical Screw N1 Trioval Conical Connection Healing Abutment N1 Trioval Conical Connection N1 Base IOS Healing Abutment Multi-Unit Abutment Trioval Conical Connection Clinical Screw N1 Base Temporary Abutment N1 Base Guided Pilot Drill N1

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device