(118 days)
Upcera Coloring Liquid (I and II) is a liquid used for the complete or partial coloration of milled Upcera zirconia substructure and anatomy before sintering.
Upcera Coloring Liquid (I and II) are water based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. Upcera Coloring Liquid I is provided in 21 different shades, and Upcera Coloring Liquid II is provided in 16 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures.
The provided text describes a 510(k) premarket notification for a medical device called "Upcera Coloring Liquid (I and II)". It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device.
The document is a submission to the FDA for a coloring liquid for dental zirconia, which is a material used in dental restorations. The "performance testing" described in Section 5.9 and Table 5.2 refers to biocompatibility testing of the coloring liquid itself, which is a standard requirement for materials that will be in contact with the human body, not a performance study of an AI device.
Therefore, I cannot provide the requested information about acceptance criteria and a study as the device described is not an AI/ML powered medical device.
§ 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.