BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premium Tray

    DI: D8451121114 · Model: 1121114 · Denplus Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Premium Tray
    Primary DI
    D8451121114
    Version / Model
    1121114
    Catalog Number
    1121114
    Company Name
    Denplus Inc
    Labeler DUNS
    202016064
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-21
    Public Version
    1
    Public Version Date
    2021-09-29
    Public Version Status
    New
    Public Device Record Key
    18a6d050-485b-4ec9-a6a2-8b3172b01000

    Device Description

    Cold-cured acrylic resin, Pink, 454 g

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBH Material, Impression Tray, Resin

    GMDN Terms

    Code Name
    58106 Dental impression tray material

    Identifiers

    Type ID
    Primary D8451121114