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510(k) Data Aggregation

    K Number
    K072830
    Device Name
    RM BOND, MODEL J032
    Manufacturer
    PENTRON CLINICAL TECHNOLOGIES
    Date Cleared
    2007-12-04

    (62 days)

    Product Code
    DYH,EBF
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K020394
    Why did this record match?
    Device Name :

    RM BOND, MODEL J032

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RM Bond Adhesive product is indicated for orthodontic applications using an indirect bonding treatment technique.

    Device Description

    The subject device is a light-cured resin adhesive in a methacrylate-based formulation; the light curing feature provides the clinician appropriate flexibility for bracket placement working-time considerations. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.

    AI/ML Overview

    This document is a 510(k) summary for a dental adhesive (RM Bond Adhesive) and does not contain the detailed study information typically found in a clinical trial report or a performance study. The provided text indicates that the device is substantially equivalent to a predicate device but does not include acceptance criteria, performance data, or study methodologies that would allow for a comprehensive answer to your questions.

    Therefore, I cannot provide the requested table or detailed information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The content is focused on regulatory submission for substantial equivalence, not on a detailed scientific or clinical study report.

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