(145 days)
Zenostar MO and Zenostar T consist of machinable zirconia discs for the preparation of full ceramic crowns, onlays and bridges (anterior and molar).
Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.
Zenostar MO (Medium Opacity) are milling discs intended for the fabrication of crown frameworks and multi-unit bridge frameworks for use as dental restorations.
Zenostar T (Translucent) are milling blanks intended for making single-tooth and multiunit restorations for use as dental restorations. Depending on the indication, frameworks or monolithic (full contour) restorations can also be made
Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.
Zenostar MO and Zenostar T are pre-sintered Zirconia discs with 98.5mm width and various thickness for use in the fabrication of dental prosthesis through the CAD/CAM milling technology. After milling, they are to be sintered at a high temperature to its full density. in order to achieve its expected physical properties. In addition, visualizer coloring liguid concentrates for dyeing Zenostar Color Zr (K11270) Solutions.
The acceptance criteria document provided describes the pre-market notification (510(k)) for dental materials, specifically Zenostar MO, Zenostar T, and Zenostar VisualiZr. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a medical device that usually involves clinical performance metrics like sensitivity, specificity, accuracy, or human interpretability.
Therefore, the following information is extracted based on the nature of this 510(k) submission, which emphasizes material properties and comparison to predicates.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this type of device are primarily compliance with ISO standards for dental ceramic materials and demonstrating equivalence in performance characteristics to the predicate device. The performance is reported in relation to these standards and the predicate.
| Acceptance Criteria (Measured Property) | Reported Device Performance (Zenostar MO/T) | Predicate Device Performance (IPS e.max ZirCAD & Zenotec Zr Bridge, Zenostar Zr Translucent) |
|---|---|---|
| Flexural Strength | Equivalent to predicate | - (Implied to meet ISO 6872:2008) |
| Chemical Solubility | Equivalent to predicate | - (Implied to meet ISO 6872:2008) |
| Coefficient of Thermal Expansion | Equivalent to predicate | - (Implied to meet ISO 6872:2008) |
| Radioactivity | Equivalent to predicate | - (Implied to meet ISO 6872:2008) |
| Biocompatibility | Equivalent to predicate ingredients | - (Implied to have demonstrated biocompatibility) |
| Indications for Use | Substantially equivalent (crowns, onlays, bridges) | Substantially equivalent (crowns, bridges) |
| Chemical Composition | Substantially equivalent | - |
| Technological Characteristics (e.g. delivery form) | Similar (but disc shape vs. block shape, different milling systems) | - |
Note: For "Zenostar VisualiZr", its performance is described as an accessory that "bears no effects on the device or its comparison to the predicate" and that "the liquid burns out almost completely during sintering. Any remaining molecules are bound in the molecular structure of the sintered restoration." This indicates that its performance is assessed by its benign interaction with the primary device.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each physical property test. It mentions that "The device has been designed and tested in accordance with ISO 6872:2008 Dentistry: Ceramic Materials for Flexural Strength, Chemical Solubility, Co-efficient of thermal expansion and Radioactivity." ISO standards typically define the minimum number of samples required for testing.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" in the context of clinical studies. Given this is a BMM (biomaterial) device, the testing would have been conducted in a laboratory setting by the manufacturer (Wieland Dental + Technik Gmbh & Co. Kg).
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 to this type of device submission. The "ground truth" for material properties is established through standardized laboratory testing protocols (e.g., ISO 6872:2008), not through human expert consensus or clinical assessment in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret data, and their disagreements are resolved. For material property testing, the results are quantitative measurements against established standards.
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 applicable. An MRMC study is relevant for AI-assisted diagnostic devices involving human interpretation of medical images or data. This submission is for dental ceramic materials, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, in terms of its properties, is established by standardized laboratory testing and measurements based on international standards (ISO 6872:2008). The expectation is that the material properties meet or exceed the requirements of these standards and are equivalent to the predicate device.
8. The sample size for the training set
This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical material, not a software algorithm.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a machine learning model.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.