(97 days)
Dental Zirconia Ceramic 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 Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe203+Er2O3+C03O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Ceramic has six models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And 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 or manual milling method.
The proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
This FDA 510(k) summary describes a Dental Zirconia Ceramic device (K222626) and its comparison to a predicate device (K183304). The submission focuses on non-clinical testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dental Zirconia Ceramic are based on the requirements specified in ISO 6872:2015 Dentistry - Ceramic materials. The reported device performance is presented as test results against these criteria.
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (Worst Case/Range) |
|---|---|---|
| Uniformity | Uniform | Uniform (for all models: Multilayer-3D, UTC, UTM, Multilayer-3D pro, SHTPC, SHTPM) |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials (for all models) |
| Radioactivity (Bq.g-1) | ≤ 1.0 (from comparison table, implied acceptance) |
§ 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.