(76 days)
HT-plus, ST, ST-C, ST-ML, SHT-C, SHT-ML, 3D-Pro-ML are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
UT, UT-C, UT-ML are intended for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior tooth region. The products have to be categorized as class 4 according to ISO 6872.
The products are suitable for CAD/CAM milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is composed of yttria-stabilized zirconia. The yttria-stabilized zirconia has a long history of safe use in dentistry.
Bloomden Dental Zirconia Blank is white, and it is composed of ZrO2+HfQz+Y2O3 and additional other oxides. Bloomden Dental Zirconia Pre-Shaded Blank is color (containing 20 available Vita shades), and it contains not only the ingredients same as the white zirconia blank but also very small amount of additional inorganic pigments (Fe2O3+E12O3+MnO). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. And there are two color representations (i.e. monolayer and multilayer) for the color zirconia blank.
The proposed device is provided in various translucency (High-plus Translucency, Super Translucency, Super-high Translucency, Ultra Translucency and 3D-Pro-ML). 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.
The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
The proposed device is a single-use device, and provided non-sterile.
The provided text describes the acceptance criteria and a study demonstrating that the "Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" device meets these criteria. This device is a dental material and not an AI/ML powered device, hence many of the requested fields are not applicable.
Here's the breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated against the requirements specified in ISO 6872:2015 Dentistry - Ceramic materials.
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (UT, UT-C, UT-ML) | Reported Device Performance (HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML) | Judgment |
|---|---|---|---|---|
| Uniformity | Uniform | Uniform | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials | Free from extraneous materials | Pass |
| Radioactivity |
§ 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.