BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    iTero Element 2 Plus, cart configuration

    DI: 00816063020684 · Model: 211483 · Align Technology, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iTero Element 2 Plus, cart configuration
    Primary DI
    00816063020684
    Version / Model
    211483
    Company Name
    Align Technology, Inc.
    Labeler DUNS
    013831768
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-04
    Public Version
    4
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    2d2b1ed3-338e-4ecf-b32a-57f6120d2859

    Device Description

    Scanner, cart configuration

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

    GMDN Terms

    Code Name
    38597 Dental milling system, CAD/CAM, chairside

    Identifiers

    Type ID
    Primary 00816063020684