(112 days)
IPS e.max CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, and full ceramic 3-unit anterior bridges.
IPS e.max ZirCAD consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays and 3- and 4-unit bridges and inlay bridges (anterior and molar.)
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding dental CAD/CAM materials (IPS E.MAX CAD/IPS E.MAX ZIRCAD). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table and information based on the given document. The document is primarily an administrative letter confirming substantial equivalence to a predicate device, not a detailed study report.
§ 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.