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510(k) Data Aggregation

    K Number
    K171167
    Device Name
    Prodigio Stain Powder
    Manufacturer
    Date Cleared
    2017-12-13

    (236 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    OperArt LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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