BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Xeno® IV Dual Cure Self-Etching Dental Adhesive

    DI: D0026680121 · Model: 668012 · DENTSPLY INTERNATIONAL INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Xeno® IV Dual Cure Self-Etching Dental Adhesive
    Primary DI
    D0026680121
    Version / Model
    668012
    Catalog Number
    668012
    Company Name
    DENTSPLY INTERNATIONAL INC.
    Labeler DUNS
    083235549
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    4
    Public Version Date
    2022-10-03
    Public Version Status
    Update
    Public Device Record Key
    f422e8f7-7f2c-4f33-a353-e8f01a7b6256
    Distribution End Date
    2019-10-28

    Device Description

    Xeno® IV Dual Cure Self-Etching Dental Adhesive Evaluator Package

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    16658 Dental impression material adhesive

    Identifiers

    Type ID
    Primary D0026680121

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K041343 000

    Device Sizes

    Type Value Unit Text
    Total Volume 2 Milliliter
    Device Size Text, specify SC Activator 2mL, XENO IV 2mL, 50 Flocked Applicator Tips, and 1 Mixing Well

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight. Keep dry.