BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K-FILES

    DI: 08806383536622 · Model: 25m/m 35 · DiaDent Group International
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K-FILES
    Primary DI
    08806383536622
    Version / Model
    25m/m 35
    Catalog Number
    SS502-207
    Company Name
    DiaDent Group International
    Labeler DUNS
    687789453
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-09
    Public Version
    1
    Public Version Date
    2020-06-17
    Public Version Status
    New
    Public Device Record Key
    2361c1a4-e4c9-4e31-8277-43253255303a

    Device Description

    Files are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EKS File, Pulp Canal, Endodontic

    GMDN Terms

    Code Name
    31878 Manual endodontic file/rasp, reusable

    Identifiers

    Type ID
    Primary 08806383536622