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510(k) Data Aggregation

    K Number
    K030072
    Device Name
    EVERSTICK PERIO
    Manufacturer
    STICK TECH LTD.
    Date Cleared
    2003-04-10

    (92 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K011788
    Why did this record match?
    Device Name :

    EVERSTICK PERIO

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

    For periodontal splinting

    Device Description

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

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a product called "everStick™ PERIO", detailing its description, intended use, and substantial equivalence to a predicate device, but it does not include performance data, study designs, or ground truth information.

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