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510(k) Data Aggregation

    K Number
    K990779
    Device Name
    HEMASEAL & CIDE
    Manufacturer
    ADVANTAGE DENTAL PRODUCTS, INC.
    Date Cleared
    1999-11-17

    (253 days)

    Product Code
    LBH,DAT
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K161077
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HEMASEAL & CIDE is to be used to seal dentinal tubules in cavity preparations or sensitive root surfaces. It also aids in wetting for tubules to provide a better bond for resin fillings and cements.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for a dental device called "HemaSeal & Cide." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria or details of a study demonstrating the device meets those criteria.

    The letter is primarily a regulatory approval based on the comparison to existing devices, rather than a performance study report. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone performance) from the provided text.

    The "Indications For Use" section on page 2 simply states what the device is intended for, not how its performance was measured or what criteria it had to meet.

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