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510(k) Data Aggregation

    K Number
    K990650
    Device Name
    CONSEAL F
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    1999-05-14

    (74 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K990652
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Pit and fissure sealant and conditioner for use in sealing pit and fissure depression of teeth.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding the clearance of a dental device named "Conseal F." It is a regulatory document and does not contain information about the acceptance criteria, study details, or performance metrics of the device.

    Therefore, I cannot provide the requested information. The document solely confirms the clearance of Conseal F as substantially equivalent to previously marketed devices based on its indications for use as a "Pit and fissure sealant and conditioner for use in sealing pit and fissure depression of teeth."

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