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510(k) Data Aggregation

    K Number
    K992629
    Device Name
    D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    1999-10-22

    (86 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K082071
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Desensitizing dentin surfaces by occluding dentin tubules with A mixture of 2 Liquids. Use under crowns And Gridges before cementation, OR for treating cervical Class V erosiono.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental desensitizer called "D/Sense® II (Green-Or)". It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

    Therefore, I cannot provide the requested information, particularly the table of acceptance criteria and reported device performance, or details about sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance. This document is a regulatory approval, not a scientific study report.

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