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510(k) Data Aggregation
(30 days)
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
BruxZir® Esthetic blanks are zirconia milling blanks used for the production of highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Esthetic restorations make them viable for use in all regions of the mouth. The manufactured dental restorations are made utilizing a CAD/CAM system for design and manufacture. The designed and manufactured dental restorations are then sintered at a high temperature. BruxZir® Esthetic blanks are available in white, bleach, and pre-shaded varieties that can be easily adjusted to match the final shade.
The provided text describes the submission for a dental device, BruxZir® Esthetic (K240882), and compares it to a predicate device (K213425). The focus of the submission is to demonstrate substantial equivalence through non-clinical testing. This is not a submission for an AI/ML powered device, and therefore, many of the requested elements related to AI/ML specific studies (e.g., MRMC studies, standalone AI performance, training set details, ground truth establishment for AI models) are not applicable.
However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets those criteria, specifically concerning the physical and chemical properties of the dental material.
Here's a breakdown of the requested information based on the provided text, while noting the inapplicability of AI/ML specific questions:
Device: BruxZir® Esthetic (K240882)
Device Type: Zirconia milling blanks for dental restorations. This is a material, not an AI/ML powered device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flexural Strength | >800 MPa (per ISO 6872:2015/Amd 1:2018, Type II Class 5) | Met the criteria (>800 MPa) |
| Visual Shade Evaluation | Grade of "Pass" for Visual Shade Match for all shades. | Met the criteria |
| Color Consistency | ΔE calculation needs to be less than 2.00 between samples measured. | Met the criteria |
| Translucency | Within 1% of the equivalent BruxZir Anterior-16 shade at 700nm. | Met the criteria |
| Coefficient of Thermal Expansion (CTE) | Between 10-11 x 10^-6 /°C, and standard deviation of CTE no greater than 0.5 x 10^-6 /°C (per ISO 6872:2015/Amd 1:2018). | Met the criteria (Reported range: 10-11 x 10^-6 /°C; implies standard deviation also met based on compliance statement) |
| Chemical Solubility | <100 µg/cm² (per ISO 6872:2015/Amd 1:2018) | Met the criteria (<100 µg/cm²) |
| Radioactivity (Uranium-238) | Not exceed 1.0 Bq/g (per ISO 6872:2015/Amd 1:2018) | Met the criteria (No more than 1.0 Bq/g) |
| Biocompatibility | Biocompatible, safe, and non-toxic (per ISO 10993-1:2018) | Met the criteria (Biocompatible and non-toxic) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each non-clinical test. It states that "the test samples were made using the standard manufacturing process and QC process for BruxZir® Esthetic."
- Data Provenance: The tests were conducted by Prismatik Dentalcraft, Inc. directly, as part of their design verification "according to BruxZir® Esthetic Design Verification Protocol." This indicates the data is prospective, generated specifically for validating the device's properties based on established industry standards (ISO). The country of origin is not explicitly stated for the testing location, but the applicant (Prismatik Dentalcraft, Inc.) is based in Irvine, California, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the studies conducted are non-clinical, laboratory-based physical and chemical property tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is the quantitative measurement against an established ISO standard.
4. Adjudication Method for the Test Set
Not applicable. The tests are quantitative measurements against predefined ISO standards. There is no human subjective adjudication process for these material property tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI-powered device, nor is it a diagnostic imaging device that would typically involve human readers. The submission focuses on the material properties of dental zirconia.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an algorithm or software device.
7. The Type of Ground Truth Used
The ground truth for these non-clinical tests is established by industry-standardized test methods (e.g., ISO 6872:2015/Amd 1:2018, ISO 10993-1:2018). The "ground truth" is adherence to the specified quantitative values and qualitative interpretations (e.g., biocompatible).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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