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510(k) Data Aggregation

    K Number
    K983545
    Device Name
    QUADRANT UNIBOND
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    1998-11-18

    (40 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Quadrant UniBond is used in the adhesive restorative technique for bonding of dental composite restorations to tooth tissue and for sealing of exposed root surfaces.

    Quadrant UniBond is used in the so-called "total etch technique", in combination with an etching agent such as Quadrant Total Etch. Conditioning of the enamel and dentin with this technique will enable the bonding agent to penetrate and seal off the cavity wall, thus forming an adhesive layer for the composite filling material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental adhesive device called "Quadrant UniBond." It does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or any of the other details requested in your prompt. This document is purely administrative, confirming that the device is substantially equivalent to previously marketed devices.

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