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510(k) Data Aggregation

    K Number
    K131043
    Device Name
    APEX UNIVERSAL ADHESIVE
    Manufacturer
    APEX DENTAL MATERIALS, INC.
    Date Cleared
    2013-09-10

    (148 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    APEX UNIVERSAL ADHESIVE

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

    Apex Universal Adhesive is a single component bonding system for:

    • Direct Restorations: to seal enamel / dentin prior to restoring with light-cure or self-cure . composite material
    • Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cements or . glass ionomer or resin-modified glass ionomer cements
    • Bonding CEREC® restorations .
    • Desensitization: to treat hypersensitive and / or exposed root surfaces .
    • Desensitizing crown preparations .
    • Sealing preparations before placing amalgams ●
    • Bonding crowns and bridges .
    • Bonding in posts and cores .
    • Bonding veneers .
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary for a dental adhesive (Apex Universal Adhesive) and does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

    This document is primarily an FDA clearance letter and an "Indications for Use" statement. It confirms that the device has been found substantially equivalent to a legally marketed predicate device, but it does not detail the specific performance studies or acceptance criteria typically associated with medical device validation. Such information would usually be found in the performance data section of the full 510(k) submission, which is not provided here.

    Therefore, I cannot provide the requested information.

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