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510(k) Data Aggregation

    K Number
    K083005
    Device Name
    NANGEL
    Manufacturer
    TEKNIMED SA
    Date Cleared
    2009-03-04

    (147 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NANGEL

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

    HYDROXYLAPATITE GEL is designed as a material intended for filling osseous defects not intrinsic to bone stability. HYDROXYLAPATITE GEL is progressively reabsorbed and replaced by bone during the rehabilitation process. The use of HYDROXYLAPATITE GEL is recommended for:

    Dental or maxillo-facial surgery:

    • Filling after surgical curettage (cysts or benign tumors)
    • Osseous defects caused by a traumatic bone lesion.
    • Treatment of alveolar wall and crest defects
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "HYDROXYLAPATITE GEL." This document primarily addresses the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.

    It does NOT contain the detailed information required to answer your specific questions related to acceptance criteria, study design, performance metrics, sample sizes, expert qualifications, or ground truth establishment for a device.

    The document states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device met the regulatory requirements for substantial equivalence, allowing it to be marketed, but the specifics of any performance studies that demonstrated this equivalence are not included in this letter.

    Therefore, I cannot provide the requested information from this document. It does not describe a study that proves the device meets specific acceptance criteria in the way you've outlined.

    To answer your questions, I would need a document that describes the clinical or performance studies conducted for the HYDROXYLAPATITE GEL, including:

    1. A table of acceptance criteria and reported device performance.
    2. Details on sample sizes and data provenance (test set and training set).
    3. Information on experts, ground truth establishment, and adjudication methods.
    4. If applicable, MRMC study details and standalone algorithm performance.
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