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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANAXDENT PMMA

    DI: 08435288491066 · Model: U 10-LAYER BLANK B1 98,5/20mm · UNION DENTAL SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ANAXDENT PMMA
    Primary DI
    08435288491066
    Version / Model
    U 10-LAYER BLANK B1 98,5/20mm
    Catalog Number
    18133120
    Company Name
    UNION DENTAL SA
    Labeler DUNS
    462114760
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-06
    Public Version
    3
    Public Version Date
    2021-10-29
    Public Version Status
    Update
    Public Device Record Key
    5bd9bab6-a660-4d1d-8587-6717886f3702

    Device Description

    ANAXDENT PMMA DISC U 10-LAYER BLANK COLOR B1 98,5/20mm

    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
    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
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    31783 Temporary dental crown/bridge

    Identifiers

    Type ID
    Primary 08435288491066

    Premarket Submissions

    Submission Number Supplement Number
    K150432 000