(88 days)
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 & Dental Zirconia Pre-Shaded 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 vttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank & Dental Zirconia Pre-Shaded 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 is a 510(k) Premarket Notification from the FDA for a dental device. It does not describe an AI/ML device, nor does it include a clinical study or a study comparing device performance against acceptance criteria in the way described in your prompt.
The document pertains to the market clearance of "Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" manufactured by Zhejiang Zahndent Biotechnology Co., Ltd. and compares it to a predicate device (K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank).
Here's why the requested information cannot be extracted from this document:
- Not an AI/ML Device: The device described is a physical dental material (zirconia blanks) used for restorations. It does not involve any artificial intelligence, machine learning, or software for diagnosis or analysis.
- No Clinical Study: The document explicitly states: "No clinical study is included in this submission" (Section 9). Therefore, there is no study concerning human readers, AI assistance, or comparative effectiveness.
- Bench Testing for Material Properties: The "studies" mentioned are bench tests performed according to ISO standards, focusing on material properties (flexural strength, chemical solubility, biocompatibility, etc.) to demonstrate substantial equivalence to a predicate device. These are not studies evaluating diagnostic performance or a reader's improvement with AI.
Therefore, I cannot provide the information requested in your prompt as it does not align with the content of the provided document. The document primarily focuses on:
- Device Description: What the dental zirconia blanks are made of and their intended use.
- Comparison to Predicate Device: Highlighting similarities and minor differences in materials and processing.
- Non-Clinical Testing Summary: Reporting the results of biocompatibility and performance tests (e.g., cytotoxicity, irritation, sensitization, toxicity, gene mutation, chromosome aberration, muscle implant) to ensure the device meets established material standards (ISO 6872:2015, ISO 13356, ISO 10993, ISO 7405). All these tests "passed," indicating compliance with the relevant standards for material safety and performance.
If you have a document about an AI/ML medical device with clinical study results, I would be able to extract the requested details.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.