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Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank 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 Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

This document describes the premarket notification for the "Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" device, which is a Class II device (Product Code: EIH). The submission aims to establish substantial equivalence to a predicate device (K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for ceramic dental materials and biocompatibility. The reported device performance indicates that the device meets these standards.

2. Sample Size and Data Provenance for Test Set

The document does not provide specific sample sizes for the "test set" in the context of clinical performance or diagnostic accuracy, as this is a material rather than a diagnostic AI device. The testing described is for material properties and biocompatibility.

• Sample Size (Material Properties): Not explicitly stated, but implies a sufficient number of samples were tested to meet the requirements of ISO 6872.
• Sample Size (Biocompatibility): Not explicitly stated, but animals were used for various tests (e.g., Syrian hamsters, guinea pigs, rats, ICR mice, rabbits), indicating standard biological testing protocols.
• Data Provenance: The studies were performed by or for Changsha Honchon Technology Co., LTD, located in China. The provenance of the raw materials (zirconia powder, inorganic pigments) is not specified, but the compliance with ISO standards indicates internationally recognized quality control. The studies are prospective bench and biological tests conducted for the purpose of this submission.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not applicable as the device is a dental material, not a diagnostic device requiring expert interpretation of images or clinical data for ground truth establishment. The "ground truth" for material properties is defined by the objective measurements according to the specified ISO standards, and for biocompatibility by the biological responses observed in controlled animal and in-vitro studies.

4. Adjudication Method for Test Set

This information is not applicable as there is no human interpretation or diagnostic decision-making being assessed that would require adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This information is not applicable as this is a dental material, not a diagnostic AI device requiring a human-in-the-loop performance study.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable as this is a dental material, not an AI algorithm. The performance studies are entirely standalone in the sense that they evaluate the material itself against predefined criteria.

7. Type of Ground Truth Used

• Material Properties: The "ground truth" is established by objective measurements and analyses against the specifications outlined in ISO 6872:2015 for various material characteristics (radioactivity, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, shrinkage factor, pre-sintered density, sintered density, and fracture toughness).
• Biocompatibility: The "ground truth" is established by observed biological responses (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local effects) in controlled in-vitro and in-vivo studies conducted according to ISO 10993-1:2018 and ISO 7405:2018, and specific parts of ISO 10993 (e.g., ISO 10993-3, -5, -6, -10, -11).

8. Sample Size for Training Set

This information is not applicable as this device is a material, not an AI-powered device that requires a training set.

9. How Ground Truth for Training Set was Established

This information is not applicable as this device is a material, not an AI-powered device that requires a training set.

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