BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CeraSeal 0.5-BOX

    DI: 08806387894841 · Model: 9484 · Meta Biomed Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CeraSeal 0.5-BOX
    Primary DI
    08806387894841
    Version / Model
    9484
    Company Name
    Meta Biomed Co., Ltd.
    Labeler DUNS
    688322841
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-06
    Public Version
    2
    Public Version Date
    2021-10-18
    Public Version Status
    Update
    Public Device Record Key
    38a4a566-ddb1-4502-9cae-dbfa1faf9bf7

    Device Description

    CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.

    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 08806387894841