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510(k) Data Aggregation

    K Number
    K120736
    Device Name
    SR PHONARES II
    Manufacturer
    IVOCLAR VIVADENT AG
    Date Cleared
    2012-05-14

    (66 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SR PHONARES II

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

    SR Phonares II denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The provided text is an FDA 510(k) clearance letter for a device called "SR PHONARES® II," which is a "Plastic Denture Tooth." This document only states that the device is "substantially equivalent" to legally marketed predicate devices and outlines general regulatory compliance information. It does not contain any technical performance data, study results, or specific acceptance criteria.

    To answer your request, I would need a document that describes the device's technical specifications, performance goals, and the results of a study designed to demonstrate those goals were met.

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