(22 days)
Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.
The PFZ™ PORCELAIN SYSTEM is a dental ceramic veneering material for fixed prosthodontics devices that include both anterior and posterior crowns/bridges.
The PFZ™ PORCELAIN SYSTEM consists of a Dentin/Transparent/Incisal porcelain, a Liner/Opaque porcelain, a Shoulder porcelain, and a Correction/Glaze/Stain porcelain in tooth colored shades.
The provided document is a 510(k) summary for the PFZ™ PORCELAIN SYSTEM, a dental ceramic veneering device. It does not describe any acceptance criteria or studies related to artificial intelligence (AI) or machine learning (ML) models.
Therefore, I cannot answer the questions regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI device.
The document focuses on demonstrating substantial equivalence to a predicate device (Cercon® Ceram S Porcelains K022796) for a traditional dental material. The stated evidence for this equivalence is based on:
- Prior use of components in legally marketed devices.
- Similarity in formulations.
- Biocompatibility testing (cytotoxicity).
§ 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.