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510(k) Data Aggregation

    K Number
    K051953
    Device Name
    EVERSTICK A&O
    Manufacturer
    STICK TECH LTD.
    Date Cleared
    2006-03-21

    (246 days)

    Product Code
    DYW
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K030072,K052477
    Why did this record match?
    Reference Devices :

    K030072

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

    For orthodontic splinting

    Device Description

    everStick® A&O is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick® A&O is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.

    AI/ML Overview

    This document is a 510(k) summary and FDA letter regarding the everStick® A&O device. It does not contain information about acceptance criteria or a study proving device performance in the context of typical AI/diagnostic device evaluation (e.g., sensitivity, specificity thresholds, sample sizes for test sets, expert consensus, MRMC studies).

    The document is a premarket notification for a medical device (glass fiber for orthodontic splinting) that is being evaluated for substantial equivalence to a predicate device, not for performance against specific diagnostic metrics.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval based on material composition and clinical use comparison to existing devices, not on quantitative performance metrics typically associated with AI or diagnostic studies.

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