BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    OsseoShaper 2

    Reg #: 9611993 · FEI: 3002807693 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    NOBEL BIOCARE AB, PRODUKTION
    Registration Number
    9611993
    FEI Number
    3002807693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    DIMBOVAGEN 2
    City
    KARLSKOGA Orebro
    Country
    SE

    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

    Manufacture Medical Device for Another Party (Contract Manufacturer)