(54 days)
The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS are for use with the Finesse™ Low-Fusing Porcelain System in conjunction with non-precious or noble or high noble alloys when used for conventional porcelain-fused-to-metal crowns, bridges or dental prostheses.
The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS contain mixtures of frits, opacifiers and pigments in varied quantities to create an assortment of materials with a variety of fusion temperatures, translucencies and colors. They contain the same silicate frits and opacifiers, and some of the same pigments used in K954761. Additional pigments used are also used in predicate medical devices. The physical properties for FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS meet the appropriate ISO Standards. The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS consist of opaque modifiers, opaque correction, dentin correction and stains, and glaze porcelains.
This 510(k) summary describes a traditional medical device (dental porcelain) and not an AI/ML-powered device. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies, which are standard for AI/ML device submissions, are not relevant and are not provided in the document.
The summary focuses on demonstrating substantial equivalence to a predicate device based on material composition, physical properties meeting ISO standards, and intended use.
Here's the relevant information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet appropriate ISO Standards | The physical properties for FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS meet the appropriate ISO Standards. |
| Components used in predicate medical devices | All of the components in the FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS have been used in predicate medical devices. |
2-9. Information not applicable for this device type.
The document refers to a "performance data" but does not elaborate on what that data entails or how it directly relates to specific acceptance criteria beyond meeting ISO standards or the prior use of components in predicate devices. There is no mention of a "study" in the sense of a clinical trial or performance evaluation with a defined test set, ground truth, or expert review.
§ 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.