BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EsTemp C&B

    DI: 08809262953749 · Model: Hexa-Temp C2 · Spident Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EsTemp C&B
    Primary DI
    08809262953749
    Version / Model
    Hexa-Temp C2
    Catalog Number
    #1204C2
    Company Name
    Spident Co., Ltd.
    Labeler DUNS
    689370711
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-20
    Public Version
    1
    Public Version Date
    2026-04-28
    Public Version Status
    New
    Public Device Record Key
    602502d0-74dc-48b2-9e68-ae241c49f203

    Device Description

    Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Primary 08809262953749