BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TEMP TABS TRUE BLUE

    DI: D8161430200 · Model: 143020 · ALL DENTAL PRODX
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TEMP TABS TRUE BLUE
    Primary DI
    D8161430200
    Version / Model
    143020
    Company Name
    ALL DENTAL PRODX
    Labeler DUNS
    002287223
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    1a51ef43-ef83-4a53-8c6d-412ba96256ea

    Device Description

    A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    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
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    34799 Composite dental impression material

    Identifiers

    Type ID
    Primary D8161430200

    Customer Contacts

    Phone
    877-647-7639
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 145 Degrees Fahrenheit