BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CERABIEN™

    DI: EKUR1030833KA0 · Model: 103-0833KA · KURARAY NORITAKE DENTAL INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CERABIEN™
    Primary DI
    EKUR1030833KA0
    Version / Model
    103-0833KA
    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
    5
    Public Version Date
    2021-08-10
    Public Version Status
    Update
    Public Device Record Key
    4bb42fee-0a99-4f43-81e1-41e0cda836d9

    Device Description

    OBA4 200g

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIH Powder, Porcelain

    GMDN Terms

    Code Name
    16187 Dental appliance fabrication material, ceramic

    Identifiers

    Type ID
    Primary EKUR1030833KA0

    Premarket Submissions

    Submission Number Supplement Number
    K992023 000