BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bonck Tack

    DI: 08800053012164 · Model: DBT2503 · DENTIS CO. ,LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Bonck Tack
    Primary DI
    08800053012164
    Version / Model
    DBT2503
    Company Name
    DENTIS CO. ,LTD
    Labeler DUNS
    694721181
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-31
    Public Version
    3
    Public Version Date
    2024-06-12
    Public Version Status
    Update
    Public Device Record Key
    c8d5d793-9ad8-445f-9ce2-3651f2f9c7ae

    Device Description

    Bonck Tack / DBT2503

    Device Characteristics

    Single Use
    Yes
    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
    MR Conditional
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZL Screw, Fixation, Intraosseous

    GMDN Terms

    Code Name
    46645 Dental regeneration membrane fixation tack, non-bioabsorbable

    Identifiers

    Type ID
    Primary 08800053012164

    Premarket Submissions

    Submission Number Supplement Number
    K222367 000