BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Estar-ZE

    DI: 08800209341285 · Model: ZEHTD3022M · Osstem Implant Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Estar-ZE
    Primary DI
    08800209341285
    Version / Model
    ZEHTD3022M
    Company Name
    Osstem Implant Co.,Ltd.
    Labeler DUNS
    694893867
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-03
    Public Version
    1
    Public Version Date
    2024-12-11
    Public Version Status
    New
    Public Device Record Key
    80dc39a1-074d-4218-9cf5-2a50ef2a6e70

    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
    Yes
    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
    EIH Powder, Porcelain

    GMDN Terms

    Code Name
    38594 Custom-made dental crown, ceramic

    Identifiers

    Type ID
    Primary 08800209341285

    Premarket Submissions

    Submission Number Supplement Number
    K242521 000