BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CLEARFIL™ SE BOND Restorative Kit

    DI: EKUR001985KA1 · Model: #1985-KA · KURARAY NORITAKE DENTAL INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CLEARFIL™ SE BOND Restorative Kit
    Primary DI
    EKUR001985KA1
    Version / Model
    #1985-KA
    Company Name
    KURARAY NORITAKE DENTAL INC.
    Labeler DUNS
    697119498
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-17
    Public Version
    3
    Public Version Date
    2021-08-10
    Public Version Status
    Update
    Public Device Record Key
    612160bd-6cc1-420d-9df3-22697f78506e

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    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
    KLE Agent, Tooth Bonding, Resin

    GMDN Terms

    Code Name
    62477 Dental composite resin kit

    Identifiers

    Type ID
    Primary EKUR001985KA1