BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Komet BioSeal Starter Kit 2.2 g

    DI: 00850008515231 · Model: KBCS1 · NUSMILE, LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Komet BioSeal Starter Kit 2.2 g
    Primary DI
    00850008515231
    Version / Model
    KBCS1
    Company Name
    NUSMILE, LTD.
    Labeler DUNS
    185497372
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-04
    Public Version
    6
    Public Version Date
    2023-06-29
    Public Version Status
    Update
    Public Device Record Key
    01abe495-d67f-4a6d-823d-ebc022b62e96

    Device Description

    For use in obturating root canals as part of orthograde root canal therapy with gutta percha.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    KIF Resin, Root Canal Filling

    GMDN Terms

    Code Name
    60510 Hygroscopic dental cement

    Identifiers

    Type ID
    Primary 00850008515231

    Device Sizes

    Type Value Unit Text
    Weight 2.2 Gram

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    72 – Degrees Fahrenheit