BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    DTX Studio™ AI SDK

    Reg #: 3005739655 · FEI: 3005739655 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Nobel Biocare c/o Medicim NV
    Registration Number
    3005739655
    FEI Number
    3005739655
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Stationsstraat 102
    City
    Mechelen Antwerpen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K221921

    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
    Analyzer, Medical Image MYN

    Proprietary Names

    DTX Studio™ AI SDK DTX Studio™ Clinic

    Establishment Types

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