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510(k) Data Aggregation

    K Number
    K202920
    Device Name
    OptiComp
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2022-05-25

    (603 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OptiComp

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

    OptiComp is a light cured hybrid dental restorative composite material used for direct restorations in all classes of cavities, including veneers and incisal edge repairs, and indirect anterior restorations, including inlays, onlays, and veneers.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria for the OptiComp device. The document is an FDA 510(k) clearance letter, which primarily focuses on regulatory approval and substantial equivalence to legally marketed predicate devices. It outlines the device's indications for use and general regulatory requirements but does not detail specific performance studies or their results.

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