(67 days)
Porcelain Powder can be used to make facings and veneers of customized denture crowns. It is suitable for adults over 18 years old.
This product includes Porcelain Powder, Stain/Glaze, Stain/Glaze-A and Modeling Fluid.
Enamel/ Modifier is Enamel porcelain, its function is to make adjusted porcelain powder gently stacked in the incisal aimed at shape, and stack from incisal to the body, covering dentin porcelain:
Stain/Glaze and Stain/Glaze-A is Enamel layer, its function is to coat with a thin layer of glaze on the surface of the finishing porcelain crown to achieve the required color and gloss of natural teeth.
Modeling Fluid: A dental ceramic powder is mixed in order to shape or model it into its required form prior to firing
The provided text is an FDA 510(k) summary for a dental product, "Porcelain Powder." It outlines the product's classification, intended use, and a comparison to a predicate device to establish substantial equivalence.
Crucially, this document is for a dental material (Porcelain Powder), not a medical device software (MDSW) or an AI/ML-driven device. Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, expert adjudication, MRMC studies, and standalone performance for AI/ML devices is not present in this regulatory submission.
The document states: "Clinical testing was not required for this submission." This indicates that no human performance or comparative effectiveness studies were conducted for this traditional material device. The "Non-clinical Test Conclusion" section primarily refers to bench testing for physical and mechanical properties, and biocompatibility testing.
To answer your prompt with the provided input, I must state that the requested information (acceptance criteria, study details for AI/ML device performance) is not applicable to the Porcelain Powder device and is not contained within this 510(k) summary.
Therefore, I cannot populate the table or provide the requested details about acceptance criteria, study design, ground truth, or expert involvement as this information pertains to a different type of medical device (AI/ML or diagnostic software) than the "Porcelain Powder" described 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.