BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive

    DI: D0026343531 · Model: 634353 · DENTSPLY INTERNATIONAL INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive
    Primary DI
    D0026343531
    Version / Model
    634353
    Catalog Number
    634353
    Company Name
    DENTSPLY INTERNATIONAL INC.
    Labeler DUNS
    083235549
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    49e68634-3245-42aa-9c99-e102c7f8b909

    Device Description

    Prime&Bond® NT™ Nano-Technology Dental Adhesive Dual Cure Introductory Kit

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KLE AGENT, TOOTH BONDING, RESIN

    GMDN Terms

    Code Name
    42483 Dentine adhesive

    Identifiers

    Type ID
    Primary D0026343531

    Customer Contacts

    Phone
    +1(800)532-2855
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 4.5 Milliliter
    Device Size Text, specify 1 Bottle Adhesive, 1 Bottle Activator, 1 Syringe Tooth Conditioner Gel, 25 Applicator Tips, 1 Brush Handle, 80 Disposable Brush Tips, 1 Dispensing Well

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight. Keep dry.
    Type
    Storage Environment Temperature
    Temperature Range
    10 – 24 Degrees Celsius