BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KometSeal

    DI: 08806387894834 · Model: 9483 · Meta Biomed Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KometSeal
    Primary DI
    08806387894834
    Version / Model
    9483
    Company Name
    Meta Biomed Co., Ltd.
    Labeler DUNS
    688322841
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-24
    Public Version
    1
    Public Version Date
    2020-04-01
    Public Version Status
    New
    Public Device Record Key
    4d53d93f-53df-41ff-9e9f-552f3bff4fa5

    Device Description

    KometsSeal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting.

    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
    KIF Resin, Root Canal Filling

    GMDN Terms

    Code Name
    36095 Endodontic filling/sealing material

    Identifiers

    Type ID
    Primary 08806387894834