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510(k) Data Aggregation
(59 days)
Zirconia Dental Ceramics are intended for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
Zirconia Dental Ceramics is composed of yttria-stabilized zirconia. It contains ZrQz+HfO2+Y2O3 and additional Al2O3 and other oxides. It offers various shapes and dimensions suitable for different milling systems. The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
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, and provided non-sterile.
This document describes the premarket notification (510(k)) for "Zirconia Dental Ceramics." The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove clinical performance or a specific diagnostic accuracy. Therefore, the questions related to AI/ML device performance (e.g., acceptance criteria for accuracy, MRMC studies, ground truth establishment for training/test sets, expert adjudication) are largely not applicable to this type of medical device submission (dental ceramics).
The acceptance criteria and "study" described in this document are focused on non-clinical performance testing to demonstrate that the physical, chemical, and biological properties of the Zirconia Dental Ceramics conform to established standards for dental ceramic materials.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:
Acceptance Criteria and Device Performance for Zirconia Dental Ceramics
The acceptance criteria for this device are based on demonstrating compliance with the international standard ISO 6872:2015 "Dentistry - Ceramic materials" and ISO 7405:2018 "Dentistry - Evaluation of biocompatibility of medical devices used in dentistry" for biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (ISO 6872:2015, etc.) | Reported Device Performance (Zirconia Dental Ceramics) | Judgment |
|---|---|---|---|
| Uniformity | Uniform (Expected for ceramic materials) | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials (Expected) | Free from extraneous materials | Pass |
| Radioactivity | ≤ 1.0 Bq.g⁻¹ | <0.017 Bq.g⁻¹ | Pass |
| Flexural strength | ≥ 800 MPa | 1076.4 MPa | Pass |
| Linear thermal expansion coefficient | (10.5 ± 0.5) × 10⁻⁶ K⁻¹ (as per predicate/reference) | 10.7 × 10⁻⁶ K⁻¹ | Pass |
| Chemical solubility | < 100 µg/cm² | 54.2 µg/cm² | Pass |
| Shrinkage factor | 1.253 ± 0.002 (as per reference device value) | 1.254 | Pass |
| Fracture Toughness | ≥ 5.0 MPa·m¹/² | 16.32 MPa·m¹/² | Pass |
| Biocompatibility Testing | Acceptance Criteria (ISO 7405:2018, ISO 10993 series) | Reported Test Results | |
| Cytotoxicity (ISO 10993-5:2009, 6.2/6.3 of ISO 7405:2018) | No cytotoxicity | No cytotoxicity under the conditions of the study | Pass |
| Skin Sensitization (ISO 10993-10:2010) | No skin sensitization | No skin sensitization under the conditions of the study | Pass |
| Oral Mucosa Irritation (ISO 10993-10:2010) | No oral mucosa irritation | No oral mucosa irritation under the conditions of the study | Pass |
| Acute Systemic Toxicity (ISO 10993-11:2017) | No acute systemic toxicity | No acute systemic toxicity under the conditions of the study | Pass |
| Subchronic Systemic Toxicity (ISO 10993-11:2017) | No subchronic systemic toxicity | No subchronic systemic toxicity under the conditions of the study | Pass |
| Genotoxicity (ISO 10993-3:2014) | No genotoxicity | No genotoxicity under the conditions of the study | Pass |
| Implantation (ISO 10993-6:2016) | No local effects | No local effects under the conditions of the study | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of test pieces for flexural strength, number of animals for biocompatibility tests). It relies on the methods outlined in the referenced ISO standards.
- Data Provenance: The tests were conducted to demonstrate conformity with international standards (ISO). The location of the testing laboratories or the origin of the data (e.g., country) is not explicitly stated, but the applicant and consultant are based in Shenzhen, China. The data is retrospective in the sense that it was collected prior to this submission for regulatory review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This is a material science and biocompatibility study, not an AI/ML diagnostic study. The "ground truth" is defined by the physical/chemical/biological properties and the standards they are measured against, not by human expert interpretation of images or clinical outcomes in the context of diagnostic algorithms. The "experts" are the scientists and technicians performing the standardized tests.
4. Adjudication Method for the Test Set
- Not Applicable. There is no human interpretation or subjective assessment that requires adjudication in these physical, chemical, and biological tests. The results are quantitative measurements or qualitative observations (e.g., presence/absence of cytotoxicity) based on standardized protocols.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device. Performance is measured against material specifications.
7. The Type of Ground Truth Used
- The "ground truth" for this device is defined by:
- International Standards: Primarily ISO 6872:2015 for physical/chemical properties and ISO 7405:2018 (and related ISO 10993 series) for biocompatibility.
- Material Science Principles: The inherent properties of the zirconia material.
- Laboratory Measurements: Quantitative and qualitative results from standardized test methods.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve machine learning; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
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