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510(k) Data Aggregation

    K Number
    K032626
    Device Name
    PERMAQUICK SE BONDING SYSTEM
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    2003-12-03

    (99 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K063558
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Us : for almost all bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure connosites, namely PermaFlo DC, also bonds to light cured PermaQuick SE. PermaQuick SE docs not recuire a separate etching step for quality adhesion. PermaQuick SE is conducive for bonding to:

      1. Dentin and Enamel using composite or amalgam
      1. Porcelain
      1. Metal
      1. Composite repair
    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification letter for the PermaQuick SF Bonding System. The letter states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain acceptance criteria or study results that prove the device meets acceptance criteria.

    The provided text is a regulatory clearance letter and an "Indications For Use" statement. It does not include:

    1. A table of acceptance criteria or reported device performance.
    2. Details about sample sizes, data provenance, number of experts, adjudication methods, or ground truth for any studies.
    3. Information about MRMC comparative effectiveness studies or standalone algorithm performance.
    4. Information about training set size or how its ground truth was established.

    Therefore, I cannot fulfill your request for this information based on the provided input.

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