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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Olympian M Temporary Cement Auto-Mix System Single Carthridge

    DI: D83600010 · Model: 0001 · DENT ZAR, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Olympian M Temporary Cement Auto-Mix System Single Carthridge
    Primary DI
    D83600010
    Version / Model
    0001
    Catalog Number
    0001
    Company Name
    DENT ZAR, INC.
    Labeler DUNS
    789664455
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-02
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    f0009426-c790-4649-995e-5d1f21a9559c

    Device Description

    Olympian M is used for cementating temporary crowns and splints. Retention of temporary crowns, sealing dressing in teeth during root canal therapy procedures.Trial cementation of permanent restorations prior to final insertion.Testing of interproximal contacts prior to final placement.

    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
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EMA Cement, Dental

    GMDN Terms

    Code Name
    46939 Fatty acid dental cement

    Identifiers

    Type ID
    Primary D83600010