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510(k) Data Aggregation

    K Number
    K030727
    Date Cleared
    2003-06-05

    (90 days)

    Product Code
    Regulation Number
    872.3275
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For luting temporary crowns to prepared crowns.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Healex Products, Incorporated, regarding their dental cement called "Preserve-Temp Plus." This document primarily addresses the substantial equivalence determination for a medical device and its intended use.

    It does not contain information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or details about standalone or MRMC studies.

    Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, number of experts, adjudication method, MRMC study details, standalone study details, type of ground truth, training set sample size, and ground truth for training set) based on the provided text. The document is an FDA approval letter, not a study report or technical specification document for the device's performance.

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