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510(k) Data Aggregation
(139 days)
Zenostar MT, Zenostar Color Liquids
Zenostar MT (medium translucency) are machinable zirconium oxide discs for the production of all-ceramic crowns, partial crowns and bridges in the anterior and posterior region.
Zenostar® MT Color Liquids are ready-made, water-based solutions for shading full contour restorations made from Zenostar MT. They are applied prior to sintering using the brush technique.
Zenostar MT are zirconia discs with 98.5mm width and 2 thicknesses, 14 mm and 18 mm. for use in the fabrication of dental prosthesis through the CAD/CAM milling technology. In addition, coloring liquids for shading full-contour restorations made from Zenostar MT.
The provided text describes the regulatory clearance (K152118) for the Zenostar MT dental material, a zirconium oxide disc used for dental restorations, and its associated coloring liquids. The submission focuses on demonstrating substantial equivalence to predicate devices (IPS e.max CAD/IPS e.max ZirCAD and Zenotec Zr Bridge, Zenostar Zr Translucent, Zenotec Color Zr, Zenostar Color Zr).
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from ISO 6872:2008 for Class 5 material - 3 unit prostheses with molar restoration) | Reported Device Performance (Zenostar MT) |
|---|---|---|
| Flexural Strength | Minimum mean of 500 MPa | >550 MPa |
| Biocompatibility | In accordance with EN ISO 10993-1:2009, EN ISO 7405:2008, EN ISO 14971:2012 | Assessed and found equivalent to predicate devices |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the sample size used for the mechanical and biocompatibility testing. The data provenance is implied to be from the manufacturer's internal testing (Wieland Dental + Technik GMBH & Co. KG), likely taking place in Germany. It is a prospective study as it's part of the device's clearance process.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" in the typical sense of diagnostic imaging studies. The evaluation is based on objective, standardized physical and chemical tests (e.g., flexural strength, chemical solubility, biocompatibility).
4. Adjudication Method for Test Set
Not applicable, as this is not a study requiring adjudication of expert interpretations but rather laboratory testing against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a material science study, not an AI-assisted diagnostic imaging or human-in-the-loop performance study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. There is no AI algorithm being evaluated in this submission.
7. Type of Ground Truth Used
The ground truth or benchmark used for evaluating the device's physical properties (like flexural strength) is the international standard ISO 6872:2008 for Dentistry: Ceramic Materials. For biocompatibility, the ground truth is established by adherence to standards like EN ISO 10993-1, EN ISO 7405, and EN ISO 14971.
8. Sample Size for Training Set
Not applicable. There is no AI algorithm with a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no AI algorithm with a training set.
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