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"ZENO Zr Disc" is a group of medical devices, which is intended to fabricate allceramic dental restorations like crowns and bridges. It consists of ceramic blanks and colorina liquids.

"ZENOTEC Zr Bridge" and "ZENOSTAR Zr translucent" are yttria stabilized zirconium dioxide (Y-TZP) ceramic (zirconia) blanks for the CAD/CAM-production of dental restorations.

"ZENOTEC Color Zr" and "ZENOSTAR Color Zr" are coloring liquids for the shading of white zirconia ceramic materials.

The products are intended to be used by professional dental technicians for fabrication of all-ceramic single tooth and bridgework restorations, with one or two pontics, in the anterior as well as in the posterior tooth region.

ZENO Zr Disc is a group of medical devices, which is intended to fabricate allceramic dental restorations like crowns and bridges. It consists of two various materials:

1.) "ZENOTEC Zr Bridge" and "ZENOSTAR Zr Translucent" are discoidal shaped and partially sintered dental ceramic materials that are composed of yttria (yttrium oxide) stabilized zirconium dioxide (Y-TZP). Both models are available in various colors, translucencies and thicknesses.

They are provided as pre-sintered blanks, which are ready to be processed in a milling machine with the CAD/CAM technology to get the desired shape, and has then to be sintered at high temperature to its full density, in order to achieve the wellknown, excellent effectiveness and safety of the zirconia.

Sintered ZENO Zr Disc materials are biocompatible, insoluble in water and have extremely high strengths. which makes it possible to manufacture delicate and filigree all-ceramic frameworks and restorations. This, together with the various available colors and translucencies of the zirconia materials, offers the basis for aesthetically pleasing, safe and effective dental restorations.

ZENO Zr Disc meets all applicable requirements of the standard ISO 6872: 2008 "Dentistry - Ceramic materials".

2.) "ZENOTEC Color Zr" and "ZENOSTAR Color Zr" are coloring liquids, which consist of watery, acidic metal salt solutions. They are intended to be used for the individual staining of dental zirconia frameworks and restorations.

They are provided in various shades. respectively. which are corresponding to every tooth color. For staining, the zirconia materials have to be immerged into the liguids (ZENOTEC Color Zr) or to be brushed with the liguids (ZENOSTAR Color Zr), before sintering at high temperatures.

Staining with ZENOTEC Color Zr or ZENOSTAR Color Zr does not have any impact on safety and efficiency of the zirconia, but only match the color of the material.

The ZENO Zr Disc device is intended for fabricating all-ceramic dental restorations such as crowns and bridges, with the aid of CAD/CAM technology. The device consists of yttria-stabilized zirconium dioxide (Y-TZP) ceramic blanks (ZENO Zr Bridge and ZENOSTAR Zr Translucent) and coloring liquids (ZENOTEC Color Zr and ZENOSTAR Color Zr).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The provided document does not specify a separate "test set" with a defined sample size in the context of a clinical study or performance verification using patient data. The claims of meeting acceptance criteria are based on bench testing against ISO standards and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The validation relies on technical specifications and established standards for dental ceramic materials.

4. Adjudication method for the test set:

This information is not applicable as there is no described test set requiring adjudication in the context of human interpretation or classification.

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 is not applicable. The device is a dental material, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

This is not applicable. The device is a dental material, not an algorithm. Its performance is inherent in its material properties and manufacturing process, not through an algorithm.

7. The type of ground truth used:

The ground truth used for establishing the acceptance criteria of ZENO Zr Disc is based on:

• International Standard ISO 6872: 2008 "Dentistry - Ceramic materials": This standard defines the performance requirements for dental ceramic materials, including properties like strength, biocompatibility, and solubility.
• Predicate devices: The device's performance is also compared to legally marketed predicate devices (Cercon base (K013230) and LAVA Frame; LAVA Frame Shade; LAVA Ceram (K011394)) to establish substantial equivalence in terms of material constituents, application process, biocompatibility, chemical solubility, and other technical performances.

8. The sample size for the training set:

This information is not applicable. The document does not describe a "training set" as this device is not an AI/ML algorithm that requires training data.

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

This information is not applicable for the same reasons as #8.

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