BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    DTX Studio design

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

    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
    K181932

    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
    Dental Abutment Design Software For Dental Laboratory PNP

    Proprietary Names

    DTX Studio design DTX Studio lab

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility