(161 days)
Unifast III is a self-curing acrylic resin used for a variety of dental applications, including construction of temporary inlays, crowns and bridges and repair of fractured dentures in either pressure or paint on techriiques.
Unifast III is a self-curing acrylic resin.
I am sorry, but the provided text does not contain the information requested about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a dental resin product called "Unifast III," confirming its substantial equivalence to a predicate device. It specifies general controls, regulations, and indications for use but does not detail performance studies, acceptance criteria, sample sizes, or ground truth establishment.
§ 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.