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510(k) Data Aggregation
(595 days)
METOXIT Z-CAD® smile blanks are indicated for the preparation of full ceramic crowns, inlays, veneers and 3 unit bridges in the anterior area. All white Z-CAD® smile blanks are indicated to be coloured with Z-CAD® Liquid smile-TC.
The Z-CAD® Liquid smile-TC will be used to dye white pre-sintered zirconia restorations milled from Z-CAD® smile blanks in the dental field.
Z-CAD® smile ceramic blanks are indicated for the production of dental-prosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology to produce dental-prosthetic restorations made from zirconium oxide. This material offers excellent properties with regards to bio-compatibility, stability and aesthetics, which make it the material of choice for the production of restorations for dental crowns, inlays, onlays, veneers, and up to three unit bridges, which in turn combine the advantages of conventional casting technology and full ceramics. Dental technicians are therefore in a position to offer patients the extra added value when finishing the prosthesis.
Metoxit Z-CAD® smile Blanks also includes Z-CAD® Liquids smile-TC. Z-CAD® Liquids smile-TC are ready for use water-based products, which are applied to the milled restauration prior to sintering to achieve individual shades. These liquids are specifically formulated for the dyeing of Z-CAD® smile blanks from Metoxit AG.
The provided text describes the 510(k) summary for the Z-CAD® Smile device, which is a dental ceramic blank used for prosthetic restorations. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study report with detailed acceptance criteria and performance data in a traditional clinical trial format.
However, I can extract the relevant information regarding performance testing and acceptance criteria for the physical properties of the device as presented, and address the other points based on the available text.
Acceptance Criteria and Device Performance Study for Z-CAD® Smile
The Z-CAD® Smile device is a dental ceramic blank. The performance data presented focuses on physical and biocompatibility properties, demonstrating its safety and effectiveness by comparison to a predicate device and established standards.
1. Table of Acceptance Criteria and Reported Device Performance (Physical Properties):
| Physical Property | Units | Z-CAD® Smile Acceptance Criteria | Reported Z-CAD® Smile Performance | Primary Predicate Device Performance | Testing Method |
|---|---|---|---|---|---|
| Bending strength (biaxial) | MPa | $\ge 500$ | 610 | > 500 | ASTM C1161 |
| Solubility (acetic acid) | µg/cm$^2$ | $\le 100$ | $\le 50$ |
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(297 days)
priti® multidisc ZrO2 High Translucent are pre-sintered zirconium oxide blanks for use in CNC (Computer Numerical Controls) milling machines to fabricate partial and single anterior and lateral crowns, bridges up to 3 units, inlays, onlays, and veneers for dental prostheses for restoration purposes only.
The priti multidisc ZrOs High Translucent blanks are made of Yttria fully stabilized zirconia (5Y-FSZ Fully Stabilized Zirconia), whereby the increased translucency is due to the higher stabilization of the zirconia base powder with yttrium oxide (Y2O3).
The priti®multidisc ZrO₂ High Translucent blanks are provided as round discs with a diameter of 98.5mm, and varying thicknesses along with 16 VITA color shades, and multicolor versions.
Here's a breakdown of the acceptance criteria and study information for the priti®multidisc ZrO2 High Translucent device, based on the provided FDA 510(k) summary:
This document describes a 510(k) premarket notification for a dental ceramic material, priti®multidisc ZrO2 High Translucent. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices. It is important to note that this document is for a material (zirconia blanks) used to fabricate dental restorations, not a diagnostic AI device. Therefore, many of the typical AI/ML study components (like expert ground truth, adjudication, MRMC studies, training/test sets for algorithms) are not applicable. The "acceptance criteria" here refer to meeting performance standards for the material itself.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the priti®multidisc ZrO2 High Translucent device are based on adherence to the ISO 6872:2015 "Dentistry - Ceramic materials" standard.
| Acceptance Criterion (ISO 6872:2015 Standard Requirements) | Reported Device Performance (priti®multidisc ZrO2 High Translucent) |
|---|---|
| Classification as Type II, Class 4 material (as per ISO 6872:2015) | Met (device classified as Type II, Class 4) |
| Radioactivity | Determined by gamma spectroscopy (met standard, implicitly) |
| Coefficient of Thermal Expansion | Determined (met standard, implicitly) |
| Chemical Solubility | Determined (met standard, implicitly) |
| Flexural Strength | Determined (met standard, implicitly) |
| Fracture Resistance | Determined (met standard, implicitly) |
| Freedom from extraneous materials | Conducted via literature-based risk estimation (met standard, implicitly) |
Note: The document states that the device "met the standard requirements per ISO 6872:2015" for its classification. Specific numerical values for the performance metrics (e.g., exact flexural strength in MPa) are not provided in this summary, but the general testing categories are listed.
2. Sample Size Used for the Test Set and Data Provenance
Given this is a material science study for dental blanks (not an AI device with a "test set" in the traditional sense):
- Sample Size: Not explicitly stated for each test. The testing was conducted on samples of priti®multidisc ZrO2 High Translucent blanks.
- Data Provenance: Not applicable in the context of patient data. The material itself is manufactured by pritidenta GmbH in Germany.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a material testing study, not a study involving human interpretation of medical images or expert consensus for ground truth. The "ground truth" is established by physical and chemical properties measured against a recognized international standard (ISO 6872).
4. Adjudication Method
- Not Applicable. There is no adjudication method described as this is not a study requiring human readers or consensus on diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not relevant for a dental material product. This type of study is typically used for diagnostic or AI-assisted interpretation systems.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not Applicable. This is a material; there is no algorithm or AI component involved.
7. Type of Ground Truth Used
- International Standard (ISO 6872:2015) and Laboratory Measurements. The ground truth is the established performance requirements outlined in the ISO standard for ceramic dental materials. The device's performance is measured in a laboratory setting to confirm it meets these predefined criteria.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
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