BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BioUniversal E

    DI: D7075925290 · Model: 592529 · IVOCLAR VIVADENT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    BioUniversal E
    Primary DI
    D7075925290
    Version / Model
    592529
    Catalog Number
    592529
    Company Name
    IVOCLAR VIVADENT, INC.
    Labeler DUNS
    176935203
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-29
    Public Version
    3
    Public Version Date
    2024-11-29
    Public Version Status
    Update
    Public Device Record Key
    73d62ecf-69b7-46ea-9e96-4b779a5a33db
    Distribution End Date
    2024-11-28

    Device Description

    BioUniversal E 5 g

    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
    No
    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
    EJT Alloy, gold-based noble metal

    GMDN Terms

    Code Name
    35858 Dental casting noble alloy

    Identifiers

    Type ID
    Primary D7075925290