BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dentitude

    DI: 06976146411090 · Model: LT-C1/D-13-10 · Fuzhou Rick Brown Biomaterials Co. Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    Dentitude
    Primary DI
    06976146411090
    Version / Model
    LT-C1/D-13-10
    Company Name
    Fuzhou Rick Brown Biomaterials Co. Ltd.
    Labeler DUNS
    416486948
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2024-04-18
    Public Version
    1
    Public Version Date
    2024-04-26
    Public Version Status
    New
    Public Device Record Key
    38168f07-c7ac-4bab-b53c-c62eebff811b

    Device Characteristics

    Single Use
    Yes
    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
    EIH Powder, Porcelain

    GMDN Terms

    Code Name
    16187 Dental appliance fabrication material, ceramic

    Identifiers

    Type ID
    Package 26976146411094
    Primary 06976146411090
    Unit of Use 16976146411097

    Premarket Submissions

    Submission Number Supplement Number
    K230487 000