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510(k) Data Aggregation
K Number
K081850Device Name
BISQUE ZIRCONIA BLANKS, TYPE BYZ
Manufacturer
ZIRCAR ZIRCONIA, INC.
Date Cleared
2008-09-25
(87 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
ZIRCAR ZIRCONIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bisque Zirconia Blanks, Type BYZ are indicated for use as a substructure for ceramic dental restorations. All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
Device Description
Zircar Zirconia Blanks, Type BYZ, 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 tight tolerances. BYZ blanks are phase stabilized with 3 mol% yttria and therefore do not undergo the usual phase transitions associated with pure zirconia. This phase transformation "toughens" the zirconia and stops crack propagation, yielding high fracture toughness and high strength. The highest purity powders are used to make Type BYZ minimizing trace oxides. Type BYZ is 99.9 wt% ZrO2 + Y203 + HfO2 + Al2O3. The natural zirconia minerals HfO2, which is so similar in structure and chemical properties to zirconia, that it has no effect on product properties. A small addition of alumina minimizes hydrothermal aging. Zircar Zirconia Blanks, Type BYZ, 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 are then 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, a metal chuck is glued on the end of blank that holds it in the CAD/CAM machine which is used to machine the final dental restoration. At he completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2.
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