BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3D Predict

    Reg #: 3016475736 · FEI: 3016475736 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3D SMILE USA INC
    Registration Number
    3016475736
    FEI Number
    3016475736
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1325 Avenue Of The Americas
    City
    New York
    State
    NY
    ZIP
    10019
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200214

    Owner / Operator

    Firm Name
    3D Smile USA Inc
    Operator Number
    10062657
    Address
    1325 Avenue of the Americas, 28th Floor, New York, NY 10019
    City
    Manhattan
    State
    NY
    Postal Code
    10019
    Country
    US
    Correspondent
    Marina Domracheva

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    3D Predict

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility