BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3Shape Ortho System

    Reg #: 3010728558 · FEI: 3010728558 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    3shape inc
    Registration Number
    3010728558
    FEI Number
    3010728558
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    430 Mountain Avenue, Suite 205
    City
    New Providence
    State
    NJ
    ZIP
    07974
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152086

    Owner / Operator

    Firm Name
    3Shape A/S
    Operator Number
    10023901
    Address
    Holmens Kanal 7
    City
    Copenhagen K
    State
    Hovedstaden
    Postal Code
    1060
    Country
    DK

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Orthodontic Software PNN

    Proprietary Names

    3Shape Ortho System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198