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510(k) Data Aggregation

    K Number
    K022300
    Device Name
    ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V
    Manufacturer
    DENTAL VIPI LTDA
    Date Cleared
    2002-10-03

    (79 days)

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

    DENTAL VIPI LTDA

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

    Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H. and Vipi Dent V Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.

    Device Description

    Not Found

    AI/ML Overview

    This document is a FDA 510(k) premarket notification letter for "Preformed Plastic Denture Teeth." It confirms that the devices are substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about acceptance criteria, device performance results, study designs, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval, not a study report. Therefore, I cannot extract the requested information.

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