(87 days)
Heany Industries Inc. Dental Zirconia is non implantable material intended for CAD/CAM fabrication of core material used in all-ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, crowns and bridges.
Heany Industries Inc. Dental Zirconia is an all ceramic core material made of zirconium oxide. It is provided as a block or cisk shape. CAD/CAM fabrication of core matcrial can then be used to produce copings and or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.
The provided text describes a 510(k) premarket notification for a dental zirconia material and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
The document is for a traditional medical device (dental zirconia blocks) and focuses on demonstrating substantial equivalence to predicate devices based on material properties, biocompatibility, and intended use.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment as it is not present in the provided text.
§ 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.