(38 days)
For making temporary prostheses, such as crowns or bridges, for use until permanent restorations can be fabricated.
Parkell's temporary C&B resin is a composite material intended for use as in the fabrication of provisional restorations for teeth prepared to receive crowns or bridges until final restorations for these teeth are completed. It is supplied in 50ml AutoMix Cartridges that automatically mix and dispense the proper ratio of base and catalyst (i.e., 1:1). The material is self-curing and sets with minimal heat and shrinkage. SmarTemp features a "rubbery" stage that permits easy trimming with scissors prior to final polymerization. SmarTemp has good physical properties and is suitable for long-term and long-span temporary restorations
The provided text is a 510(k) Summary for a dental product called "SmarTemp Temporary C&B Resin". It describes the product, its intended use, and its substantial equivalence to other legally marketed predicate devices.
However, the summary does not contain any information about specific acceptance criteria, study designs, sample sizes, or performance data for the "SmarTemp" device. The document is typical of a 510(k) summary from 1999, which primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics and intended use, rather than presenting detailed performance study results against predefined acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text. The document only states that the device has "good physical properties" but does not quantify them or provide data from a study.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.