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510(k) Data Aggregation

    K Number
    K091852
    Device Name
    BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205
    Date Cleared
    2009-09-10

    (79 days)

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

    REFRACTRON TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Refractron Technologies Corporation Bisque Zirconia Blanks (Type BYZ), are indicated for use as a substructure for ceramic dental restorations.
    Device Description
    Refractron Porcelain Powder Blanks are high purity, bisque fired zirconia machining blanks. The powders pressed to form these blanks are of a uniform size and well dispersed, ensuring no agglomerates. The resultant fine-grained, bisque body allows intricate shapes to be machined with specified tolerances. Refractron Technologies Corporation Blanks (exactly Zircar Zirconia, Inc. Blanks) are dental ceramic blanks designed for the manufacturing of substructures for ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining or using the copying technique. Products are either porous or dense. Porous blanks can then be sintered to full density and strength. Dense blanks do not need a final heat treatment and are therefore ready for veneering immediately after machining. All appliances are for the sole use of the particular patient only. At the dental lab (Refractron's customer that processes the blanks) a metal chuck is glued on the end of the blank that holds it in the CAD/CAM machine which is used to machine the final dental restoration. At the completion of the machining steps, the dental restoration is fired, i.e. sintered, in the oven to harden the ZrQ2.
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