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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.

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.

The provided text is a 510(k) summary for a dental device (Bisque Zirconia Blanks, Type BYZ) seeking substantial equivalence to predicate devices. This type of submission relies on demonstrating that the new device has the same intended use and similar technological characteristics, or if different, that it is as safe and effective and does not raise new questions of safety and effectiveness.

Therefore, the study design elements typically associated with AI/ML-driven medical devices (such as clinical trials with detailed acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this 510(k) submission.

The document states: "By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics. But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device."

It concludes: "As such, it has been shown in this 510(k) submission, that the differences between the Bisque Zirconia Blanks, Type BYZ and the predicate devices do not raise any questions regarding their safety and effectiveness."

Answer based on the provided text:

This 510(k) submission is for Bisque Zirconia Blanks, Type BYZ, which are dental ceramic blanks. The submission is based on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a traditional clinical study with detailed performance metrics.

Therefore, the following information is not provided or not applicable in this 510(k) summary:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission asserts substantial equivalence based on intended use and technological characteristics being similar to predicate devices, or if different, that safety and effectiveness are equivalent and no new questions are raised. No specific performance metrics or acceptance criteria are presented for the device in the provided text.

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert-established ground truth for a test set is described.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-driven diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a material for dental restorations, not an algorithm.

7. The type of ground truth used: Not applicable. No ground truth is established as no clinical study with performance metrics is described.

8. The sample size for the training set: Not applicable. There is no algorithm, and therefore no training set.

9. How the ground truth for the training set was established: Not applicable. There is no algorithm, and therefore no training set.

The submission focuses on the intended use (substructure for ceramic dental restorations) and technological characteristics (high purity, bisque fired zirconia machining blanks, phase stabilized with 3 mol% yttria, 99.9 wt% ZrO2 + Y2O3 + HfO2 + Al2O3) to argue for substantial equivalence to the predicate devices:

• Sagemax Z-Blank (K062695)
• Vita In-Cream YZ Cubes for Cerec (K022996)

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