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510(k) Data Aggregation

    K Number
    K131049
    Device Name
    ZRP
    Manufacturer
    APEX DENTAL MATERIALS, INC.
    Date Cleared
    2013-08-27

    (134 days)

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

    ZRP

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

    ZrP is an ethanol based primer that improve the bond strengths of zirconia oxide restorations to restorative cements and bonding agents.

    Device Description

    ZrP is an ethanol based primer

    AI/ML Overview

    This is an FDA 510(k) clearance letter for a dental product, ZrP, a resin tooth bonding agent. This document does not contain information about acceptance criteria or a study demonstrating the device meets such criteria because it's a clearance letter, not a full submission or study report.

    The letter confirms that the FDA has reviewed Apex Dental Materials' 510(k) premarket notification for ZrP and determined it is "substantially equivalent" to legally marketed predicate devices. This means that ZrP is considered as safe and effective as existing devices on the market, but the letter itself does not provide the detailed study results or acceptance criteria that led to this determination. Such information would typically be found within the 510(k) submission itself (which is often extensive and includes bench testing, biocompatibility, and sometimes clinical data).

    Therefore, I cannot populate the requested table and details based on the provided text. The document is merely the FDA's decision letter.

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