(321 days)
Zircon Blanks are used for milling using digital stl-files to produce Crowns, Bridges and monolithic works. We propose the K2 Zircon Blanks for anterior and posterior restorations.
Table 1: Indication of use and maximum intermediate elements.
| Single crown | Bridges | |||
|---|---|---|---|---|
| Anterior | Posterior | Anterior | Posterior | |
| K2 Zircon Blank | ||||
| white classic | X | X | 2 | 2 |
| K2 Zircon Blank | ||||
| translucent | X | X | 2 | 2 |
| K2 Zircon Blank | ||||
| extreme translucent | X | X | 1 | - |
All K2 Zircon Blanks are indicated to be colored with Dip & Brush K2 CAD CAM Zircon Liquids. K2 Zircon Blanks should be not used by the general public or over-the-counter.
The Yeti K2 Zircon Blanks are ceramic blanks, which are indicated for the production of dentalprosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology and for milling using digital STL files to produce Crowns, Bridges and monolithic works made from zirconium oxide.
The Yeti Dip & Brush K2 liquids are ready for use water-based products. These liquids are specifically formulated for the colorization of K2 Zircon Blanks from Yeti Dentalprodukte GmbH.
This document is a 510(k) premarket notification for a dental device, specifically Zirconium Oxide blanks used for milling dental restorations. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) is not applicable to this type of submission.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific acceptance criteria in the form of performance thresholds (e.g., in terms of accuracy, sensitivity, or specificity) for the device itself in a study format. Instead, it demonstrates substantial equivalence to predicate devices based on:
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (K2 Zircon Blanks) |
|---|---|---|
| Chemical Composition | Comparable to predicate device (> 99.5% ZrO2 + HfO2 + Y2O3) | > 99.5% ZrO2 + HfO2 + Y2O3 |
| Shapes and Dimensions | Comparable to predicate devices | Disks (Diameter: 95 or 98.5 mm, Height: 10 to 25 mm) |
| Bulk Density | No significant deviations to predicate devices | Tested for each batch |
| Grain Size | No significant deviations to predicate devices | Tested for each batch |
| Flexural Bending Strength | No significant deviations to predicate devices | Tested for each batch |
| Fracture Toughness | No significant deviations to predicate devices | Tested for each batch |
| Hardness (Vicker's) | No significant deviations to predicate devices | Tested for each batch |
| Coefficient of Thermal | No significant deviations to predicate devices | Tested for each batch |
| Radioactivity (raw material) | No significant deviations to predicate devices | Tested for each batch |
| Solubility (acetic acid) | No significant deviations to predicate devices | Tested for each batch |
| Biocompatibility | Compliance with ISO 10993-1 standards | Tested for cytotoxicity, haemolysis, acute systematic toxicity, irritation, sensitization, pyrogen, chromosomal abbreviation and long-term implantation; all performed in accordance with ISO 10993-1. |
| Shelf Life | Established shelf-life | 10 years |
| Sintering Parameters | Identical to predicate device | 1450°C - 2 hours, 1500°C - 1 hour |
Note: The document explicitly states: "Except for the K2 Zircon Blank white classic, there was no comparable value found for the specifications translucency and Thermal conductivity" for the predicate device. This indicates that for these specific properties, direct comparison was not possible, but it doesn't indicate a failure to meet acceptance criteria, as the overall substantial equivalence argument is based on the totality of characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission for a dental material (zirconium oxide blanks), not an AI/software device. Therefore, there is no "test set" in the context of an AI study for diagnostic performance. The "tests" mentioned are material property tests and biocompatibility tests.
- Sample Size: Not specified in terms of a "test set" as understood in AI studies. The performance data refers to "bench test for each raw material or product batch" and "biocompatibility evaluation." The number of samples for these tests is not quantified in the provided text, but it implies ongoing quality control and a specific evaluation for biocompatibility.
- Data Provenance: Not applicable in the context of clinical data for AI; the data refers to material testing conducted by the manufacturer, Yeti Dentalprodukte GmbH, in Germany. The biocompatibility tests were conducted according to ISO 10993-1.
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 section is not applicable. The device is a dental material, not a diagnostic device requiring expert interpretation or ground truth establishment in the diagnostic sense. The "ground truth" for material properties is established through standardized physical and chemical tests (e.g., ISO standards, lab measurements).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. There is no "test set" for diagnostic performance and no human interpretation requiring adjudication in this 510(k) submission.
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 section is not applicable. An MRMC study is relevant for comparing human reader performance with and without AI assistance for diagnostic tasks. This device is a dental material, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device relates to its physical, chemical, and biological properties. This is established through:
- Standardized material testing: Measurements of properties like chemical composition, bulk density, grain size, flexural bending strength, fracture toughness, hardness, coefficient of thermal expansion, radioactivity, and solubility. These are objective laboratory measurements, not subjective expert consensus.
- Biocompatibility testing against ISO standards: Compliance with ISO 10993-1, which involves specific tests for cytotoxicity, haemolysis, etc.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is a material rather than an AI or machine learning algorithm.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it is irrelevant in this context.
§ 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.