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510(k) Data Aggregation

    K Number
    K102450
    Device Name
    IONOLUX PRO
    Manufacturer
    VOCO GMBH
    Date Cleared
    2010-10-08

    (42 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Ionolux Pro is intended for the following applications:

    1. Restorations class III and V, especially cervical fillings and root caries
    2. Fillings on deciduous teeth
    3. Small class I fillings
    4. Temporary fillings
    5. Core build-up
    6. Lining
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a device called "Ionolux Pro," which is a "Tooth Shade Resin Material" used in dentistry. This document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. It details the indications for use of the device but offers no performance data, study designs, sample sizes, expert qualifications, or ground truth methodologies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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