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510(k) Data Aggregation

    K Number
    K022025
    Device Name
    MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
    Manufacturer
    MILTON HODOSH, M.D.
    Date Cleared
    2002-08-15

    (56 days)

    Product Code
    EJK
    Regulation Number
    872.3250
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K022025
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FOR LINING AND BASES UNDER AMALGAM AND/OR Composite RESTORATIONS AND FOR LUTING FULL CROWNS TO PREPARED TEETH.

    Device Description

    Not Found

    AI/ML Overview

    This document is a letter from the FDA to Dr. Milton Hodosh regarding the 510(k) premarket notification for the "Preserve Cavity Liner" (later referred to as not yet named, but a modification of "Potassium MIRRY's Lycon Epoxy LGTF DEVITAL CEMENT").

    The letter approves the device as substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

    The document is an approval letter for a medical device based on its substantial equivalence to previously approved devices, not a study report. Therefore, I cannot extract the requested information from this text.

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