BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Light Bond

    DI: D798BILBP0 · Model: BILBP · RELIANCE ORTHODONTIC PRODUCTS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Light Bond
    Primary DI
    D798BILBP0
    Version / Model
    BILBP
    Catalog Number
    BILBP
    Company Name
    RELIANCE ORTHODONTIC PRODUCTS INC
    Labeler DUNS
    113170088
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-10
    Public Version
    1
    Public Version Date
    2018-09-10
    Public Version Status
    New
    Public Device Record Key
    6c242a7e-8562-4036-986d-a5113dc4c6b0

    Device Description

    Light Bond is intended for use as a light cure bracket and lingual retainer adhesive. Light Bond™ LIGHT CURE SEALANT AND BRACKET BONDING SYSTEM KIT WITH FLUORIDE PRODUCT FEATURES: SMOOTH, TACKY PASTE VISCOSITY: The viscosity of Light Bond™ Regular Paste is very tacky which helps prevent bracket flotation. NO MIXING - UNLIMITED WORKING TIME: Light Bond™ is a photo initiated adhesive that offers the operator unlimited working time to position brackets and clean flash. BONDS TO METAL, CERAMIC & COMPOSITE SURFACES: Light Bond™ will bond to any enamel, porcelain, composite or metal surface, when properly conditioned. This is the two syringe kit configuration, NonFluoride

    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
    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 D798BILBP0

    Customer Contacts

    Phone
    630-773-4009
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K895522 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Light Bond can be handled and stored at ambient temperatures