BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Light Cure Adhesive

    DI: 00192029000069 · Model: 151-105 · TP ORTHODONTICS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Light Cure Adhesive
    Primary DI
    00192029000069
    Version / Model
    151-105
    Company Name
    TP ORTHODONTICS INC
    Labeler DUNS
    005432299
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-13
    Public Version
    2
    Public Version Date
    2019-12-23
    Public Version Status
    Update
    Public Device Record Key
    0bd6dd1e-9add-4003-8714-dc23c5edee68

    Device Description

    TURBO BOND II LIGHT CURE BONDING REPLACEMENT MATERIAL, Paste in Syringe, 4 g (.141 oz) Medium to Low Viscosity

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    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 00192029000069

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 27 Degrees Celsius