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510(k) Data Aggregation

    K Number
    K171167
    Manufacturer
    Date Cleared
    2017-12-13

    (236 days)

    Product Code
    Regulation Number
    872.6660
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Prodigio Stain Powder

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

    The Prodigio Stain Kit is 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'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 Prodigio Stain Kit is ideal for high and low production laboratories and is available in 16 classic Vita® shades as well as Neutral Brown, Complex 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 Prodigio Stain Kit fire at 900 degrees C

    Prodigio Stain Kit is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 750 degrees C

    Device Description

    The Prodigio Stain Powder includes the following 6 sets of stains and dental porcelains:

    Prodigio Stain Kit is 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'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 Prodigio Stain Kit is ideal for high and low production laboratories and is available in 16 classic Vita® shades as well as Neutral Brown, Complex 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 Prodigio Stain Kit fire at 900 degrees C

    Prodigio Stain Kit is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 750 degrees C

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria or a study proving device performance.

    The document is a 510(k) premarket notification letter from the FDA regarding "Prodigio Stain Powder". It states that the device is substantially equivalent to legally marketed predicate devices, meaning it meets the general controls provisions of the Act for medical devices.

    The content focuses on:

    • Identification of the device: Prodigio Stain Powder (K171167).
    • Regulatory classification: Class II, Product Code EIH.
    • General regulatory compliance: Registration, listing, labeling, good manufacturing practices, etc.
    • Indications for Use: Describes the Prodigio Stain Powder as a porcelain stain system for dental use, emphasizing its easy application, natural fluorescent properties, and ability to mimic natural tooth appearance. It also mentions two specific kits (Prodigio Stain Kit and SN2000Y kit) with different firing temperatures and available shades.

    Therefore, I cannot provide the requested table or details about a study as this information is not present in the given text.

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