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510(k) Data Aggregation

    K Number
    K060565

    Validate with FDA (Live)

    Date Cleared
    2006-05-08

    (66 days)

    Product Code
    Regulation Number
    872.3590
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Nanofilled, semi anatomical plastic teeth composed of polymethylmethacrylate intended for use as teeth in full or partial dentures.

    Device Description

    Nanofilled, semi anatomical plastic teeth composed of polymethylmethacrylate

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device called CONDYLOFORM II NFC. This document details the regulatory approval process and includes the indications for use for the device.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details you are asking for regarding a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information based on the input text.

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