LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K051573
    Device Name
    TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
    Manufacturer
    DR. HOWARD MARTIN, P.A.
    Date Cleared
    2006-06-26

    (377 days)

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

    TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)

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

    Gutta percha is inserted into rout canal following root canal preparation.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device named "TGP" (Gutta Percha). It confirms the device's substantial equivalence to legally marketed predicate devices.

    This document does not contain any information about:

    • Acceptance criteria for a device's performance.
    • Any study that proves the device meets acceptance criteria.
    • Sample sizes for test sets or training sets.
    • Data provenance.
    • Number of experts used to establish ground truth or their qualifications.
    • Adjudication methods.
    • Multi-reader multi-case comparative effectiveness studies.
    • Standalone algorithm performance studies.
    • Types of ground truth used.

    Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about a study, as this information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1