(56 days)
belleGlass HP Modeling Gel is a filled resin used as a pre-wetting agent for placing and sculpting layers of composites and it is to be used between layers of cured composite.
belleGlass HP Modeling Gel will make the processing of the belleGlass restorations easier and faster and will improve the quality of the restorations by making the system more user friendly. belleGlass HP Modeling Gel is 50% filled with fine radiopaque reinforcing fillers of 0.4micron average particle size. The gel is similar to "flowable composites" and will assure a strong intimate bond between composite layers as well as reducing the chances of dilution of the enamel and dentin surfaces. By using the belleGlass HP Modeling Gel, surfaces will be less sticky, making it easier to sculpt and after processing easier to polish. The results are closer margins, stronger restorations, and savings of time increasing productivity.
I am sorry, but the provided text from K020178 is a 510(k) summary for a dental modeling gel. It focuses on the chemical composition, intended use, and substantial equivalence to a predicate device.
It does not contain any information about acceptance criteria, study designs, sample sizes, expert ground truth, or performance metrics that would be relevant for describing a typical AI/ML device study.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.