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510(k) Data Aggregation

    K Number
    K022265
    Device Name
    LIGHT TIP
    Date Cleared
    2002-10-02

    (82 days)

    Product Code
    Regulation Number
    872.6070
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Light Tip is intended to concentrate the energy and guide the beam to the bottom of the preparation when curing composite materials. The deep composite will therefore be cured first which strengthens the filling, creates contact points and reduces the contraction gap.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental device called "Light Tip." It discusses regulatory aspects, such as substantial equivalence to a predicate device, and general controls, but it does not include any performance study data, acceptance criteria, sample sizes, expert qualifications, or ground truth information. It only provides the indications for use of the device.

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