(331 days)
Non-Sterile Zirconia Block (Model: Finebase, Montblanc, Trione C, Trione HT+) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Non-Sterile Zirconia Block (Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) is a manufacture unit that is cut, processed and sintered by CAD/CAM system of the computers designed for production of dental restoration.
The provided text is a 510(k) Summary for a dental device (Non-Sterile Zirconia Block) and does not describe the acceptance criteria or a study that proves a device (likely an AI/ML-enabled medical device) meets acceptance criteria. The document explicitly states:
"No clinical study is included in this submission." (page 4)
Therefore, I cannot extract the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or adjudication methods from this specific document.
The document focuses on non-clinical tests (material properties and biocompatibility) to demonstrate substantial equivalence to a predicate device, rather than clinical performance (e.g., accuracy of a diagnostic AI).
§ 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.