BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iTero Element 5D Imaging System, Certified Pre-owned

    Reg #: 2953749 · FEI: 3002519584 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Align Technology, Inc.
    Registration Number
    2953749
    FEI Number
    3002519584
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2820 Orchard Parkway
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193659

    Owner / Operator

    Firm Name
    Align Technology, Inc.
    Operator Number
    9035576
    Address
    410 North Scottsdale Road, Suite 1300
    City
    Tempe
    State
    AZ
    Postal Code
    85281
    Country
    US

    Products

    Device Name Product Code
    Caries Detector, Laser Light, Transmission NTK

    Proprietary Names

    iTero Element 5D Imaging System, Certified Pre-owned iTero Element 5D Plus iTero Element 5D Plus Mobile iTero Element 5D iTero Element 5D, Full barrier sleeve iTero Element 5D Laptop Configuration

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198