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510(k) Data Aggregation

    K Number
    K023818
    Device Name
    FIBERFILL AGP
    Manufacturer
    PENTRON CLINICAL TECHNOLOGIES
    Date Cleared
    2003-04-03

    (139 days)

    Product Code
    KIF,EKM
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FIBERFILL AGP

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

    Fiberfill AGP is a root canal filling resin used for endodontic therapy to fill the root canal of a tooth.

    Device Description

    Fiberfill™ AGP

    AI/ML Overview

    This is a notification of intent to market a device, not a study report. Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. These types of details would typically be found in a clinical study report or a pre-market approval (PMA) application, not in a 510(k) clearance letter.

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