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510(k) Data Aggregation

    K Number
    K983751
    Device Name
    QUADRANT UNICHEM
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    1998-11-30

    (38 days)

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

    Quadrant UniChem is a two component, self-curing curing dental composite filling material, including an etching agent (Quadrant Total Etch) and a two component, selfcuring enamel bonding agent, used in the adhesive restorative technique for the restoration of decayed teeth.

    Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue.

    Quadrant UniChem is a composite for universal use: the restoration of both anterior and posterior teeth. It can also be used for core build-up: the reconstruction of a tooth with insufficient material left as a result of decay, before crown preparation.

    Device Description

    Quadrant UniChem is a two component, self-curing curing dental composite filling material, including an etching agent (Quadrant Total Etch) and a two component, selfcuring enamel bonding agent.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental composite filling material called "Quadrant UniChem." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

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