BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BONDPRO™ METAL ENHANCER 10cc

    DI: 10190886000588 · Model: M956-01 · G & H Wire Company, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BONDPRO™ METAL ENHANCER 10cc
    Primary DI
    10190886000588
    Version / Model
    M956-01
    Company Name
    G & H Wire Company, Inc.
    Labeler DUNS
    831465641
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    bfd860db-c3e8-4b52-b7c5-18f2bcc6fb9c
    Distribution End Date
    2017-02-10

    Device Description

    METAL ENHANCER 10cc. APPLIED PRIOR TO BONDING FOR STRONGER BONDS.

    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
    DYH Adhesive, Bracket And Tooth Conditioner, Resin

    GMDN Terms

    Code Name
    34782 Dentine bonding agent/set

    Identifiers

    Type ID
    Primary 10190886000588

    Customer Contacts

    Phone
    +1 317-346-6655
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K981036 000