BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Nobel Biocare c/o Medicim NV

    Reg #: 3005739655 · FEI: 3005739655 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    Nobel Biocare c/o Medicim NV
    Registration Number
    3005739655
    FEI Number
    3005739655
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Stationsstraat 102
    City
    Mechelen Antwerpen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K252086

    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
    Medical Device Data System OUG
    Automated Radiological Image Processing Software QIH
    Analyzer, Medical Image MYN
    System, Image Processing, Radiological LLZ
    Abutment, Implant, Dental, Endosseous NHA
    Dental Abutment Design Software For Dental Laboratory PNP
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    DTX Studio Core DTX Studio™ Assist DTX Studio™ AI SDK DTX Studio™ Clinic DTX Studio Clinic IPS CaseDesigner DTX Studio lab DTX Studio design NobelDesign DTX Studio Design DTX Studio Lab DTX Studio diagnose NobelDesign Software DTX Studio Implant

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device