BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MatrixTemp Temporary Crown and Bridge Material

    DI: 00859787002024 · Model: 102 · ADVANTAGE DENTAL PRODUCTS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MatrixTemp Temporary Crown and Bridge Material
    Primary DI
    00859787002024
    Version / Model
    102
    Company Name
    ADVANTAGE DENTAL PRODUCTS INC
    Labeler DUNS
    607859147
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-21
    Public Version
    3
    Public Version Date
    2021-10-29
    Public Version Status
    Update
    Public Device Record Key
    1e844dec-6d28-47a1-8350-e5ec22605a31

    Device Description

    Self-cure resin based impression material for the fabrication of temporary crowns and bridges

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    45236 Temporary dental crown/bridge resin

    Identifiers

    Type ID
    Package 10859787002021
    Primary 00859787002024

    Customer Contacts

    Phone
    248-391-1625
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 50 Milliliter

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Use with adequate ventilation and store away from oxidizing materials
    Type
    Storage Environment Temperature
    Temperature Range
    – 73 Degrees Fahrenheit
    Type
    Handling Environment Temperature
    Temperature Range
    – 73 Degrees Fahrenheit