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510(k) Data Aggregation

    K Number
    K974283
    Device Name
    PQ 1
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    1998-01-29

    (76 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

    PQ 1 PermaQuick Bonding System is used for 95% of bonding needs in restorative dentistry. Ease of use I Q 1 t offinaQuick Donaling Cycleral as PQ 1 the agent of choice for all light cure bonding needs. PQ 1 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

    I apologize, but the provided text is a letter from the FDA regarding a medical device, not a study describing its acceptance criteria and performance. Therefore, I cannot extract the requested information, as the document does not contain details about:

    • Acceptance criteria and reported device performance in a table format.
    • Sample sizes, data provenance, number of experts, or ground truth establishment for test sets.
    • Adjudication methods.
    • MRMC comparative effectiveness studies or standalone algorithm performance.
    • Training set sample size or ground truth establishment.

    The document primarily focuses on the FDA's substantial equivalence determination for the "PQ 1 PermaQuick Bonding System" and its intended uses.

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