Search Results

The spray glaze ZENOSTAR Magic Glaze is a ready to use and easy to apply, spray on ceramic glaze, which is primarily intended for ZENOSTAR Zr restorations, manufactured with the help of the ZENOTEC Systems. However, veneered zirconium oxide restorations, (ZIROX and ZENOFLEX dimension) and metal ceramic restorations (REFLEX and REFLEX dimension) can also be glazed with the spray glaze ZENOSTAR Magic Glaze. ZENOSTAR Magic Glaze spray glaze can be used together with and/or at the same time as the relevant specific ceramic stains.

ZENOSTAR Magic Glaze is dental porcelain, which is made of glass frit and is applied in an aerosolized form. It can be used by professional dental technicians to glaze dental porcelain -fused-to-metal as well as all-ceramic restorations, like milled zirconium dioxide crowns and bridges.

This application method decreases the production time compared to the conventional build-up methods, where glaze ceramic powder has to be mixed with suitable liquids and layered onto the restoration with a brush.

After spraying on, ZENOSTAR Magic Glaze has to be fired at about 900°C for 1-2 minutes in a ceramic furnace to achieve its final properties.

Generally, the glaze bake determines the surface finish of the ceramic veneer and thereby significantly affect the esthetical appearance of the restoration. ZENOSTAR Magic Glace allows spraying on even and very thin layers of glace material, thus providing the possibility to control shining and optical reflection of the restoration by repeating the procedure.

It can be applied on single unit or multiple unit restoration at one time, and, in addition, it can be sprayed over unfired ceramic stains and body-stains, which are often used to match the color of the patient's natural teeth. These possibilities save time of additional firing cycles and enhance the efficiency of the application of ZENOSTAR MAGIC Glaze.

The provided text is a 510(k) summary for ZENOSTAR Magic Glaze, a dental ceramic spray glaze. It details the device's description, intended use, and comparison to a predicate device for the purpose of demonstrating substantial equivalence.

However, the document does not contain specific acceptance criteria for performance metrics, nor does it detail a study that proves the device meets such criteria in terms of quantitative performance (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance).

Instead, the document asserts substantial equivalence based on the device's physical, biological, and chemical properties meeting demands of international accepted standards (like ISO 6872 for bending strength, and ISO 7405 for biocompatibility).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text because such specific performance criteria and a study to prove them are not present. The document focuses on demonstrating equivalence through material properties and intended use.

Here's a breakdown of what can be extracted or inferred based on the questions, even if direct answers for performance criteria and a specific study are absent:

1. Table of Acceptance Criteria and the Reported Device Performance:

   Acceptance Criteria (Inferred from standards)	Reported Device Performance (Inferred from compliance statements)
   Meets ISO 6872 (Bending Strength)	"meet their demands"
   Meets ISO 7405 (Biocompatibility)	"meet their demands"
   Meets standards for Chemical Solubility	"meet their demands"
   Safe and Effective	"as safe, as effective, and performs as well as or better than the predicate device."

   Note: The document only generally states that the device meets the "demands" of these standards, without providing specific numerical thresholds for acceptance or the measured values of the ZENOSTAR Magic Glaze.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not provided in the given text. This type of evaluation is not relevant for a materials science submission like this.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided in the given text. This type of evaluation is not relevant for a materials science submission like this.

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:

   • This information is not provided in the given text. This device is a material (ceramic spray glaze), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This information is not provided in the given text. This device is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For a material like dental porcelain, the "ground truth" for its properties (bending strength, biocompatibility, chemical solubility) would typically be established through laboratory testing according to established international standards (e.g., ISO 6872, ISO 7405). These standards define the test methods and performance requirements. The text explicitly mentions compliance with these standards.

8. The sample size for the training set:

   • This information is not provided in the given text. This is not relevant for a materials science submission, as there is no "training set" in the machine learning sense.

9. How the ground truth for the training set was established:

   • This information is not provided in the given text. This is not relevant for a materials science submission.

Ask a specific question about this device