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510(k) Data Aggregation
(76 days)
HT-plus, ST, ST-C, ST-ML, SHT-C, SHT-ML, 3D-Pro-ML are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
UT, UT-C, UT-ML are intended for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior tooth region. The products have to be categorized as class 4 according to ISO 6872.
The products are suitable for CAD/CAM milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is composed of yttria-stabilized zirconia. The yttria-stabilized zirconia has a long history of safe use in dentistry.
Bloomden Dental Zirconia Blank is white, and it is composed of ZrO2+HfQz+Y2O3 and additional other oxides. Bloomden Dental Zirconia Pre-Shaded Blank is color (containing 20 available Vita shades), and it contains not only the ingredients same as the white zirconia blank but also very small amount of additional inorganic pigments (Fe2O3+E12O3+MnO). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. And there are two color representations (i.e. monolayer and multilayer) for the color zirconia blank.
The proposed device is provided in various translucency (High-plus Translucency, Super Translucency, Super-high Translucency, Ultra Translucency and 3D-Pro-ML). 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.
The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
The proposed device is a single-use device, and provided non-sterile.
The provided text describes the acceptance criteria and a study demonstrating that the "Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" device meets these criteria. This device is a dental material and not an AI/ML powered device, hence many of the requested fields are not applicable.
Here's the breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated against the requirements specified in ISO 6872:2015 Dentistry - Ceramic materials.
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (UT, UT-C, UT-ML) | Reported Device Performance (HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML) | Judgment |
|---|---|---|---|---|
| Uniformity | Uniform | Uniform | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials | Free from extraneous materials | Pass |
| Radioactivity | <0.02 Bq.g$^{-1}$ (Implicit based on predicate comparison in Table 1, and actual measured values) | <0.02 Bq.g$^{-1}$ | <0.02 Bq.g$^{-1}$ | Pass |
| Flexural strength | UT, UT-C, UT-ML: $\geq$ 500 MPa | 864.3 MPa | 1238.2 MPa | Pass |
| HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML: $\geq$ 800 MPa | ||||
| Chemical solubility | $<$ 100 µg.cm$^{-2}$ | 13.5 µg.cm$^{-2}$ | 11.8 µg.cm$^{-2}$ | Pass |
| Linear thermal expansion coefficient | (10.5 $\pm$ 0.5) $\times$ 10$^{-6}$ K$^{-1}$ | 10.0 $\times$ 10$^{-6}$ K$^{-1}$ | 10.5 $\times$ 10$^{-6}$ K$^{-1}$ | Pass |
| Shrinkage factor | Not explicitly stated as a single value criterion, but expected to be consistent within a range | 1.244, 1.243, 1.243 | 1.244, 1.245, 1.241 | Pass |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in the provided text for each specific test. The phrase "the test results showed that the proposed device meets the requirements specified in the standard" implies that sufficient samples were tested to satisfy the ISO standard, but the exact numbers are not detailed.
- Data provenance: The tests were "performed according to ISO 6872:2015 Dentistry - Ceramic materials" and "ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry". The location where these non-clinical tests were conducted is not specified beyond the applicant's address in Hunan, China. The data is non-clinical performance testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as the study involved non-clinical performance and biocompatibility testing of a material, not the evaluation of a diagnostic device or algorithm requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
Not applicable, as this was non-clinical laboratory testing against ISO standards, not a study requiring human adjudication of results.
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:
Not applicable. This device is a dental material, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used:
For the performance tests, the "ground truth" was established by the requirements and methodologies outlined in the ISO 6872:2015 standard. For biocompatibility, the "ground truth" was established by the requirements and methodologies outlined in the ISO 7405:2018 and ISO 10993 series standards. These are objective, quantitative measures of material properties and biological responses.
8. The sample size for the training set:
Not applicable. This is a material, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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