(90 days)
The Multilayered Zirconia Disc is indicated for fabrication of anterior and posterior dental restorations using different CAD/CAM or manual machines. All discs are processed through dental laboratories or by dental professionals.
DenMat Multilayered Zirconia Discs are made of Zirconium Oxide (Y-TZP ZrO2). For dental applications in accordance with ISO 6872, (DIN EN ISO 6872), this material is specially made for manufacturing of permanent and removable dental prosthetics. After completion of the final sintering, all DenMat Multilayered Zirconia meets the requirements of ISO 6872, Type II, Class 5. It is necessary to mill the disc with an appropriate enlargement factor to account for the shrinkage that occurs during full sintering. DenMat Zirconia Multilayered (ML) discs can be used with any compatible CAD/CAM machine.
Material Used:
DenMat Multilayered Zirconia Discs are composed of zirconia ceramics (ZrO2) based on yttria-stabilized tetragonal zirconia (Y-TZP). The material is biocompatible according to ISO 10993-1: 2018 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"
The provided FDA 510(k) clearance letter and summary for the DenMat Multilayered Zirconia Disc do not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing AI assistance to human readers.
Instead, the document describes the physical and chemical properties of a dental material (zirconia discs) and compares them to a predicate device. The performance data presented are results from laboratory tests conducted on the material itself, not clinical studies involving human readers or AI algorithms for disease detection/diagnosis.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device clearance.
However, I can extract the acceptance criteria and performance data for the material's physical properties as presented in the document.
Acceptance Criteria and Reported Device Performance (for Material Properties)
The acceptance criteria and reported performance relate to the physical and chemical properties of the DenMat Multilayered Zirconia Disc, as evaluated against ISO standards for dental ceramics.
Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance (Single Crown) | Reported Device Performance (Single Crown Units & 3 Unit Bridges) | Applied Standard | Result |
|---|---|---|---|---|---|
| Biaxial Flexural strength | ≥ 100 MPa (for Single Crown) | ||||
| ≥ 500 MPa (for Single Crown Units & 3 Unit Bridges) | 568.72 ± 168.22 MPa | 740.45 ± 252.32 MPa | ISO 6872: 2024 | Pass | |
| Coefficient of Thermal Expansion (CTE) | 10.40 ± 0.34 (x10⁻⁶ K⁻¹) | 10.40 ± 0.02 (x10⁻⁶ K⁻¹) | 10.43 ± 0.05 (x10⁻⁶ K⁻¹) | ISO 6872: 2024, ASTM E831 | Pass |
| Chemical solubility | 1.0 MPa√m (for Single Crown) |
3.5 MPa√m (for Single Crown Units & 3 Unit Bridges)
Minimum for Class 5: 4.0 MPa√m (overall) | 4.14 ± 0.43 MPa√m | 4.21 ± 0.48 MPa√m | ISO 6872: 2024 (ISO 18756/ASTM C1421) | Pass |
| Sintered Density | ≥ 6.0 g/cm³ | 6.11 ± 0.05 g/cm³ | 6.05 ± 0.03 g/cm³ | ISO 13356: 2015 | Pass |
| Radioactivity | Not more than 1.0 Bq g⁻¹ of Uranium238 | 800 MPa | 1085.51 ± 265.06 MPa | N/A (Tested once for material composition) | ISO 6872: 2024 | Pass |
Non-Applicable or Unknown Information (Due to the Nature of the Device)
The following information pertains to AI/ML device studies and is not applicable to this 510(k) for a dental material:
- Sample size used for the test set and the data provenance: Not applicable. These are laboratory tests on material samples, not patient data. The quantity of material samples tested is not explicitly stated in the summary, but typical for these types of tests (e.g., multiple specimens for each property). Data provenance is "lab testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by adherence to certified test methods and instrumentation, not expert consensus on medical images/data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental material, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for material properties is defined by the physical/chemical standards and measurements themselves as per ISO and ASTM guidelines (e.g., measured force for flexural strength, measured mass change for solubility).
- The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the DenMat Multilayered Zirconia Disc is a dental material, and its acceptance criteria and proving study focus on demonstrating that its physical and chemical properties meet established international standards (ISO, ASTM) for dental restorative materials, ensuring its safety and effectiveness for its intended use. It is not an AI software device, and therefore the assessment methodologies typically associated with AI/ML-based medical devices do not apply here.
§ 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.