(28 days)
Willi Geller Creation CP Porcelain is a pressable ceramic material intended for constructing veneer, onlay, inlay, and crown substructures and full contour restorations. Veneering of substructures can be performed with suitable conventional or low fusing porcelains such as Willi Geller Creation GC or Willi Geller Creation LF (K02904).
Willi Geller Creation CP porcelain consists of pressable ceramic pellets that are used by dental technicians to fabricate full contour restorations (crowns, onlays, inlays, veneers) and substructures for full ceramic demtal restorations that are completed by being veneered with conventional or low fusing dental porcelains.
This document, K043221, is a 510(k) Pre-market Notification for a dental porcelain product called "Willi Geller Creation CP Porcelain." As such, it does not contain the kind of study information you are asking for, which is typical for diagnostic medical devices or those with more complex performance claims. This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on mechanical properties, chemical qualities, and indications for use, rather than clinical performance metrics like sensitivity, specificity, or reader studies.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.
The document states: "Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation CP substantially equivalent to the predicate device Match Press pressable ceramic. The safety and effectiveness of Willi Geller Creation CP, being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices."
This implies that the "study" for this device involved comparing its physical and chemical properties to those of the predicate device (Match Press pressable ceramic, K024250) to establish substantial equivalence. However, the details of these comparisons (e.g., specific tests, acceptance criteria, results) are not included in the provided 510(k) summary.
§ 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.