LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060086
    Device Name
    FENIIIIIIX COLORATION KIT
    Manufacturer
    DENTAL ARTE, INC.
    Date Cleared
    2006-03-03

    (51 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FENIIIIIX system includes the following 6 sets of stains and dental porcelains:

    FENIIIIIX COLORATION KIT SN2000Y a porcelain stain system designed for easy application and natural fluorescent properties. This dental porcelain stain system can be used with most commercially available porcelain restorations where porcelain's ability to mimic natural tooth appearance is important. The system provides optimum esthetics with the most consistently reliable results for the full range of shades.

    The FENIIIIIX COLORATION KIT stain system is ideal for high and low production laboratories and is available in 16 classic Vita® shades as well as Neutral Brown, Complex Gray, Blue Gray, Ochre; Rust and Red for matching bleached dentition with CTE Ranges of 13.7 to 15.1. The full assortment is 22 Stains, 1 powdered glaze and 1 liquid glaze.

    The stains in the SN2000Y kit fire at 900ºC

    • FENIIIIIX COLORATION KIT SN200Y is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 750°C
      FENIIIIIX SUPER LIGHT WHITE KIT, a stain kit designed to produce perfectly white dental restorations. It includes one powdered stain and 1 liquid glazon

    • FENIIIIIX SPEACIAL CLEAR KIT, This kit includes a series of whites designed to produce areas of whitish translucence and opalescence.

    • ASTARTE SUPER WHITE PORCELAIN KIT. This kit is specifically designed to create perfectly white dental restorations and can be used with most commercially available base and precious metal, dental alloys that are designed for porcelain fused to metal applications. It includes 1 powdered opaque, 1 powdered enamel, 1 powdered colorless glaze, 1 liquid opaque and 1 liquid dentine.

    • FENI///// ELIMINCRACK. This kit is used to repair cracks that form in porcelain dental restorations. It includes 1 powdered porcelain and 1 repair liquid.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification for a dental porcelain product named FENIIIIIIX. It describes the product's indications for use and states that it has been deemed substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to assessing the performance of a device using AI or human readers.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or any other details about studies as none of that information is present in the text you've provided.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1