(29 days)
Temporary C&B composite is a fluorescent cold polymerising pastepaste system for the production of temporary crowns, bridges, inlays and onlays. Temporary C&B composite consists of base paste and catalyst paste.
Temporary C&B composite is a fluorescent cold polymerising pastepaste system for the production of temporary crowns, bridges, inlays and onlays. Temporary C&B composite consists of base paste and catalyst paste.
The provided text is a 510(k) clearance letter from the FDA for a dental product, "Temporary C&B Composite." It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.
However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, or any other specifics related to a study proving the device meets acceptance criteria.
The letter is an administrative document, confirming the device's clearance based on equivalence, not a summary of a performance study. Therefore, I cannot extract the requested information from the provided text.
§ 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.