(33 days)
the LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veners) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing.
The LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veneers) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing.
The provided text does not contain information about specific acceptance criteria, device performance, or a study demonstrating that the device meets such criteria.
The document is a 510(k) summary for "The LF-P Ceramic System," a dental porcelain. It states that data has been presented to demonstrate that the mechanical properties, chemical qualities, and indications for use make the device substantially equivalent to predicate devices. It also mentions that the safety and effectiveness are determined by chemical qualities, cytotoxicity test results, and mechanical properties. However, it does not provide the specific values for these properties or the methodologies of any studies conducted to evaluate them.
Therefore, I cannot provide the requested 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.