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510(k) Data Aggregation

    K Number
    K233544
    Device Name
    MESHEET
    Manufacturer
    Dentis Co., Ltd
    Date Cleared
    2024-02-22

    (111 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K192847,K222619
    Why did this record match?
    Reference Devices :

    K192847

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

    The MESHEET is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

    Device Description

    MESEEHT is a thermoplastic aligner designed according to the patient to help maintain teeth to the final desired position. This MESHEET is to be removed for eating and for cleaning.

    MESHEET is sequence of transparent aligner manufacture from digital scan/plan.

    Each aligner delivers a unique combination of minor forces to create the planned tooth movement. MEHSEET has a main layer that material is poly ethylene and mesh layer that material is thermoplastic polyurethane. Among the main layer, mesh layer is added.

    MESEEHT is sequence of transparent aligners created from a digital orthodontic treatment plan and thermoplastic aligners designed according to the patient to help maintain teeth to the final desired position. This MESHEET is to be removed for eating and for cleaning.
    MESHEET is sequence of transparent aligner manufacture from digital scan/plan. The digital orthodontic treatment plan is created by a dental health professional. Each aligner delivers a unique combination of minor forces to create the planned tooth movement. MESHEET has cross shape holes MEHSEET has main layer that material is poly ethylene and mesh layer that material is thermoplastic polyurethane. Among the main layer. mesh layer is added.

    AI/ML Overview

    The provided text describes a medical device called MESHEET, an orthodontic plastic aligner, and its substantial equivalence to a predicate device. However, it does not contain information about the acceptance criteria or a specific study proving the device meets acceptance criteria in the context of an AI/software performance evaluation.

    The "Non-Clinical Testing" section mentions some tests were conducted, but these are general medical device validations and not a performance study for a diagnostic or prognostic AI algorithm. The tests mentioned are:

    • Biocompatibility tests (cytotoxicity, irritation, Acute systemic toxicity, Bacterial reverse mutation, In vitro chromosome aberration, Intramuscular tests) in accordance with ISO 10993-1. These are for material safety.
    • OTS software validation test according to FDA guidance. This is for the software used in the manufacturing process, not for an AI that interprets medical data.
    • Manufacturing Process Validation Testing to validate the fit, form, and function of the final product and ensure it achieves its intended use. This is a manufacturing quality control, not an AI performance study.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or AI-specific study details because this information is not present in the provided document. The document primarily focuses on establishing substantial equivalence to a predicate device based on intended use, materials, technical characteristics, and standard medical device safety and manufacturing tests, not on the performance of an AI or software that makes diagnostic/prognostic decisions.

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