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510(k) Data Aggregation

    K Number
    K190569
    Device Name
    Shaders ZR
    Date Cleared
    2019-07-29

    (145 days)

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

    Digital Age Dental Lab

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns, and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a dental laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions.
    Device Description
    Shaders™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in different sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM)". Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
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