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    K Number
    K023819
    Device Name
    FIBERFILL SGP
    Manufacturer
    PENTRON CLINICAL TECHNOLOGIES
    Date Cleared
    2003-03-26

    (131 days)

    Product Code
    EKM
    Regulation Number
    872.3850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FIBERFILL SGP

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

    Fiberfill SGP is a root canal filling thermal plastic composite material used for endodontic therapy to fill the root canal of a tooth in replacing conventional Gutta Percha material.

    Device Description

    Fiberfill SGP is a root canal filling thermal plastic composite material.

    AI/ML Overview

    This document is an FDA letter regarding the clearance of a medical device, Fiberfill™ SGP, as substantially equivalent to a predicate device. It does not contain information about acceptance criteria, device performance, or any studies using AI. The letter is a regulatory approval document and not a scientific study report.

    Therefore, I cannot provide the requested information based on the provided text. The document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance.
    6. Results of a standalone algorithm study.
    7. Type of ground truth used in a study.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.
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