BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Core-Flo DC Lite

    DI: D757AB17410K1 · Model: AB-17410K · BISCO INC.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Core-Flo DC Lite
    Primary DI
    D757AB17410K1
    Version / Model
    AB-17410K
    Catalog Number
    AB-17410K
    Company Name
    BISCO INC.
    Labeler DUNS
    053529939
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-19
    Public Version
    2
    Public Version Date
    2022-10-11
    Public Version Status
    Update
    Public Device Record Key
    7a983b72-b86b-4d3e-a90d-6edb7d55c021
    Distribution End Date
    2022-10-10

    Device Description

    Core-Flo DC Lite with Universal Primer Kit

    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
    EBF MATERIAL, TOOTH SHADE, RESIN
    EID SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
    KLE Agent, Tooth Bonding, Resin
    KXR Applicator, Resin

    GMDN Terms

    Code Name
    62477 Dental composite resin kit

    Identifiers

    Type ID
    Primary D757AB17410K1

    Customer Contacts

    Phone
    +1(847)534-6000
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    20 – 25 Degrees Celsius