BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BONDPRO™ AUTOMIX DUAL CURE BAND CEMENT KIT

    DI: 10190886000700 · Model: M976K-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™ AUTOMIX DUAL CURE BAND CEMENT KIT
    Primary DI
    10190886000700
    Version / Model
    M976K-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
    4
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    657a3431-909b-48eb-96d4-bf4723dfea54
    Distribution End Date
    2017-02-14

    Device Description

    Full Kit. A unique dual cure composite resin cement ideally suited for cementing metal molar bands. Chemically bonds to both tooth structure and metal band to create a strong anchor. The glass ionomer technology creates high tensile and compressive strength, reducing washout and loose bands. The cement is ideally mixed and has no strong odor or aftertaste. The adhesive can be light cured to immediately set band in place. Without light activation, a complete set is achieved in five minutes. Contains fluoride for added tooth protection. Easily dispensed from economical screw syringes or in smart automix system. Kit contents: 4x 10gm syringes (5gm catalyst & 5gm base), 50 sheet mixing pads, 30 dispensing tips, instructions.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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
    31750 Orthodontic bracket adhesive

    Identifiers

    Type ID
    Primary 10190886000700

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K981036 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    50 – 75 Degrees Fahrenheit