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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Oxford MTA Handmix

    DI: EFSM400020 · Model: 40-002 · First Scientific Dental Materials GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Oxford MTA Handmix
    Primary DI
    EFSM400020
    Version / Model
    40-002
    Company Name
    First Scientific Dental Materials GmbH
    Labeler DUNS
    341553292
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-24
    Public Version
    1
    Public Version Date
    2020-12-02
    Public Version Status
    New
    Public Device Record Key
    12340648-ea89-4554-bfc8-ff43d114111f

    Device Description

    Endodontic Repair Cement

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KIF Resin, Root Canal Filling

    GMDN Terms

    Code Name
    36095 Endodontic filling/sealing material

    Identifiers

    Type ID
    Primary EFSM400020

    Customer Contacts

    Phone
    +494121909508
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    10 – 25 Degrees Celsius