LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992484
    Device Name
    RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG
    Manufacturer
    JORDCO, INC.
    Date Cleared
    1999-10-14

    (80 days)

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

    RCNG: Root Canal Negotiating Gel is used for instrument negotiation and debreedment of root canal systems during root canal therapy.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the device "RCNG: Root Canal Negotiating Gel." It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    However, the provided text does not contain any information about:

    • Acceptance criteria for device performance.
    • A study that proves the device meets any acceptance criteria.
    • Device performance data.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts for ground truth.
    • Adjudication methods.
    • Multi-Reader Multi-Case (MRMC) studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth was established for training or testing.

    The document is a regulatory approval letter, not a device performance study report. Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1