(90 days)
Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
Dental Glass Ceramics is composed of SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides. The block is intended to be 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 block is a single-use device and provided non-sterile.
The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
The provided document is a 510(k) Premarket Notification from the FDA for a dental material (Dental Glass Ceramics), not an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and study details for an AI-powered device.
Specifically, the document focuses on demonstrating substantial equivalence of the Dental Glass Ceramics to a predicate device based on material properties, intended use, and biocompatibility, as per ISO 6872 and ISO 10993 standards. It includes:
- A comparison table (Table 1) showing the proposed device and predicate device are "Same" across numerous characteristics like product code, classification regulation, indications for use, materials, crystallization state, device design, shades, single use, principle of operation, sterility, type/class per ISO 6872, mechanical properties (flexural strength, chemical solubility, radioactivity, linear thermal expansion, glass transition temperature) and biocompatibility.
- Biocompatibility testing results (Table 2) demonstrating that the material passed cytotoxicity, oral mucosa irritation, skin sensitization, subacute systemic toxicity, acute systemic toxicity, in vitro mammalian cell gene mutation, bacterial reverse mutation, and muscle implant tests. These tests are standard for evaluating the safety of implantable or device-contacting materials.
- A statement that no clinical study was included in the submission.
Therefore, it is impossible to extract the requested information about acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, or training set details from this document. The nature of the device (dental material) and its regulatory pathway (510(k) for substantial equivalence to a material predicate) do not necessitate or include such information.
§ 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.