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510(k) Data Aggregation
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Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Dental Zirconia Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe203+Er2O3+C03O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Ceramic has six models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
This FDA 510(k) summary describes a Dental Zirconia Ceramic device (K222626) and its comparison to a predicate device (K183304). The submission focuses on non-clinical testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dental Zirconia Ceramic are based on the requirements specified in ISO 6872:2015 Dentistry - Ceramic materials. The reported device performance is presented as test results against these criteria.
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (Worst Case/Range) |
|---|---|---|
| Uniformity | Uniform | Uniform (for all models: Multilayer-3D, UTC, UTM, Multilayer-3D pro, SHTPC, SHTPM) |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials (for all models) |
| Radioactivity (Bq.g-1) | ≤ 1.0 (from comparison table, implied acceptance) | <0.021 (range: <0.018 to <0.021 for all models) |
| Flexural Strength (Mpa) (Class 4) | ≥ 600 MPa (for Multilayer-3D, UTC, UTM models) | 635.60 (Multilayer-3D, Incisal end) to 840.69 (UTC) to 725.34 (UTM). All values meet or exceed 600 MPa for these models. |
| Flexural Strength (Mpa) (Class 5) | ≥ 800 MPa (for Multilayer-3D pro, SHTPC, SHTPM models) | 985.15 (Multilayer-3D pro) to 950.95 (SHTPC) to 1014.51 (SHTPM). All values meet or exceed 800 MPa for these models. |
| Chemical Solubility (µg/cm²) | < 100 µg/cm² | 5 (SHTPM) to 38 (Multilayer-3D pro) (range: 5 to 38 for all models) |
| Linear Thermal Expansion Coefficient (×10-6 K-1) | Not explicitly stated as acceptance criteria, but predicate comparison shows Not publicly available for predicate. | Incisal end: 10.4, Middle part: 10.3, Root end: 10.3 (Multilayer-3D); 10.1 (UTC); 10.5 (UTM); 10.5 (Multilayer-3D pro); 10.3 (SHTPC); 10.4 (SHTPM) |
| Biocompatibility | Compliant with ISO 7405:2018 and specific ISO 10993 standards | No cytotoxicity, no skin sensitization, no oral mucosa irritation, no acute or subchronic systemic toxicity, no genotoxicity, no local effects from implantation. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of samples for flexural strength, radioactivity, etc.). It only states that "Performance tests were performed according to ISO 6872:2015". ISO standards often define minimum sample sizes for specific tests.
The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin of the data. However, the applicant is Aidite (Qinhuangdao) Technology Co., Ltd. from China, so it is reasonable to infer the tests were conducted or overseen by them, likely in China or at a facility compliant with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The device's performance is evaluated against material standards (ISO 6872:2015), not against human interpretation or diagnosis. Therefore, there is no "ground truth" established by experts in the context of medical image analysis or similar applications. The results are objective measurements.
4. Adjudication method for the test set
This section is not applicable as the evaluation is based on objective material property measurements against an international standard, not expert review or diagnostic assessment.
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. This submission is for a dental material (zirconia ceramic), not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a material device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical testing is the established scientific and engineering principles and measurement methodologies defined in international standards, specifically ISO 6872:2015 for ceramic materials and various ISO 10993/7405 standards for biocompatibility. The compliance is measured against the specifications and test methods outlined in these standards.
8. The sample size for the training set
This section is not applicable. The submission is for a manufactured material product, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable as there is no training set.
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