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510(k) Data Aggregation

    K Number
    K973636
    Device Name
    MCS-MEDICATED CANAL SEALER
    Manufacturer
    DR. HOWARD MARTIN, P.A.
    Date Cleared
    1998-07-27

    (306 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MCS-MEDICATED CANAL SEALER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in the sealing of prepared root canals in adult or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to seal canal walls, to promote healing effects and to help preserve the sealer and sealer / gutta percha interface.

    Device Description

    MCS - Martin's Canal Sealer

    AI/ML Overview

    This is a 510(k) clearance letter for a dental device, not a study report for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth cannot be extracted from this document.

    The document discusses the regulatory clearance of "MCS - Martin's Canal Sealer" and states its intended use for sealing root canals. It confirms that the device is substantially equivalent to a legally marketed predicate device, indicating it meets the general controls provisions of the Federal Food, Drug, and Cosmetic Act.

    No information regarding AI/ML performance, acceptance criteria, or studies proving such criteria are met is present in this document.

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