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510(k) Data Aggregation

    K Number
    K111814
    Device Name
    PADLOCK
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2011-09-14

    (79 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K001048
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Light Bond is intended for use as an orthodontic bracket adhesive.

    Pad Lock® is intended for use as a fluorescing, light cure Orthodontic Bracket Adhesive.

    Device Description

    Light Bond and Pad Lock are light cure, orthodontic bracket adhesives available in a variety of viscosities for bonding to metal, ceramic and composite surfaces. Both Light Bond and Pad Lock are available in fluoride and non-fluoride formulas and come in syringe style or tip dispensing.

    In addition, Pad Lock fluoresces to ease clean-up of flash for the user.

    AI/ML Overview

    The provided document is a 510(k) summary for orthodontic bracket adhesives (Light Bond™ and Pad Lock®). It is not a study report for an AI-powered device. Therefore, I cannot extract information about acceptance criteria or a study proving that an AI device meets acceptance criteria, as an AI device is not described in this document.

    The document discusses the substantial equivalence of the Light Bond™ and Pad Lock® products to a predicate device (QUICK CURE, K001048), focusing on their intended use and mechanical/physical properties as orthodontic bracket adhesives.

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