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510(k) Data Aggregation

    K Number
    K240419
    Device Name
    UltraThineer Zirconia Slurry (5Y-B)
    Date Cleared
    2024-04-12

    (59 days)

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

    Boston Micro Fabrication

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UltraThineer Zirconia Slurry is indicated for use by dental technicians in the construction of custommade ceramic restorations. These include copings, crowns, inlays and onlays, veneers, and bridges (3-unit anterior bridges).
    Device Description
    The UltraThineer Zirconia Slurry is a ceramic slurry intended for use in fabricating custom-made ceramic restorations using 3D printing and sintering processes. There is a single formulation: Zirconia-5Y/BMF-5YZ-1.6B. The UltraThineer Zirconia Slurry is provided as a slurry contained in a sealed tamper-proof and opaque HDPE bottle, with product labeling. The bottle containing the slurry has dimensions of 3.5" in diameter and 7.75" in height and has a maximum volume of 0.75L. For use, the slurry is poured into a vat inside the 3D printer for printing the dental veneer. After printing, the veneer is sintered to yield the final product. Each veneer will be custom fabricated on a named patient prescription basis on the order of a dentist.
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