(127 days)
BeCe CAD Zirkon HT+ is indicated for the fabrication of single crowns and bridgework.
- Fully anatomical crowns and bridges -
- Partial-veneered and fully veneered crowns and bridges -
- Dentine core crowns and bridges -
- Maryland bridges -
- Telescopic crowns (primary part) -
BeCe CAD Zirkon HT+ consists of yttria stabilized zirconia and is suitable for the fabrication of dental ceramic restorations. BeCe CAD Zirkon HT+ is available as milling blank and is processed by milling technique.
The provided text describes a dental product, "BeCe CAD Zirkon HT+", and its substantial equivalence to a predicate device based on meeting certain industry standards. However, it does not contain information about acceptance criteria for an AI/ML device, a study proving an AI/ML device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document is a 510(k) summary for a dental material (zirconia powder), not an AI/ML device. Therefore, it does not address any of the specific points requested in the prompt regarding AI/ML device evaluation.
§ 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.