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X-cera Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

X-cera Zirconia Blanks are provided in either block, disc, cylinder shape and are derived from zirconia powder that has been processed via uni-axial die pressing, followed by iso-static pressing, to achieve final net shapes of uniform density and distribution. These Zirconia Blanks can be fabricated into various prosthetic dental device.

X-cera Zirconia Blanks are offered in ten(10) different product families of shapes and a multitude of different sizes as shown in Figure 1 and Table 1 and are capable of being machined into complex dental shapes using modern machining methods and are similar to the sizes and shapes of the predicate device.

The document describes the submission of "X-cera Zirconia Blanks" for 510(k) premarket notification. The information provided outlines the device's technical specifications and a study conducted to demonstrate its substantial equivalence to a legally marketed predicate device, "Aidite Zirconia Dental Ceramics (K111291)".

Here's an analysis of the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with international standards (ISO 6872, ISO 10993, ISO 7405) and internal design specifications. The reported device performance confirms compliance with these criteria through a series of non-clinical tests.

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