BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORTOLUX TOP

    DI: 08435288433721 · Model: ANTERIOR TEETH D3/1NN · UNION DENTAL SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ORTOLUX TOP
    Primary DI
    08435288433721
    Version / Model
    ANTERIOR TEETH D3/1NN
    Catalog Number
    D3D31NN
    Company Name
    UNION DENTAL SA
    Labeler DUNS
    462114760
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-18
    Public Version
    1
    Public Version Date
    2024-09-26
    Public Version Status
    New
    Public Device Record Key
    4c4bd45f-fd1c-4fdc-8e11-7f78a3668122

    Device Description

    ORTOLUX TOP anterior Teeth Shade D3, Mould 1NN

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELM Denture, Plastic, Teeth

    GMDN Terms

    Code Name
    38643 Resin artificial teeth

    Identifiers

    Type ID
    Primary 08435288433721

    Premarket Submissions

    Submission Number Supplement Number
    K070591 000