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510(k) Data Aggregation

    K Number
    K251252
    Device Name
    NOBILCAM IMPAK Disc
    Manufacturer
    Shandong Huge Dental Material Corporation
    Date Cleared
    2025-08-01

    (100 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K003817,K111828
    Why did this record match?
    Device Name :

    NOBILCAM IMPAK Disc

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

    The NOBILCAM IMPAK Disc is a heat cured, moldable, acrylic compound for use in the fabrication of dental appliances and dental prostheses devices including TMJ splint appliances, nightguards, bruxism appliances and other devices as prescribed.

    Device Description

    The NOBILCAM IMPAK Disc contains a cured disc, to be used in a CAD/CAM machine to produce an occlusal splint for suffering patients. NOBILCAM IMPAK Disc is mainly composed of acrylic resin and manufactured through compression molding. Depending on the different CAD/CAM machines used for the product, NOBILCAM IMPAK Disc is designed into various specifications and shades to meet different needs.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) Clearance Letter does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies for an AI/CADe device.

    The document describes the regulatory clearance for a dental material device called "NOBILCAM IMPAK Disc", which is an acrylic compound used for fabricating dental appliances.

    It focuses on:

    • Physical and Chemical Properties Tests: These are bench tests comparing the material properties (e.g., appearance, dimension, color stability, water sorption, hardness, flexural strength) of the subject device to a predicate device and relevant ISO/ADA standards.
    • Biocompatibility Tests: These are biological safety tests performed according to ISO 7405 and ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).
    • Technological Characteristics Comparison: A table comparing ingredients, physical form, indications for use, sterility, storage conditions, and packaging with predicate and reference devices.

    There is no mention of:

    • An AI or CADe device.
    • Any diagnostic or detection performance metrics (e.g., sensitivity, specificity, AUC).
    • Human reader studies or multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Ground truth established by experts or pathology.
    • Sample sizes for training or test sets for an algorithm.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on this document, as the document pertains to a physical dental material, not an AI software or diagnostic device that would typically have the performance metrics and study types you've listed.

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