BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Luminesse ZR Incisal Translucents

    DI: D7911977W0 · Model: 1977W · TALLADIUM, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Luminesse ZR Incisal Translucents
    Primary DI
    D7911977W0
    Version / Model
    1977W
    Company Name
    TALLADIUM, INC.
    Labeler DUNS
    094430642
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-24
    Public Version
    4
    Public Version Date
    2018-07-24
    Public Version Status
    Update
    Public Device Record Key
    5b2591f5-c8d5-48ef-b389-b1ad2004808e

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIH Powder, Porcelain

    GMDN Terms

    Code Name
    16187 Dental appliance fabrication material, ceramic

    Identifiers

    Type ID
    Primary D7911977W0

    Premarket Submissions

    Submission Number Supplement Number
    K140848 000