(70 days)
Kerr Compomer is a light-curable dental restorative material containing a fluoride releasing agent intended to be used in dentistry as a filling material for all class cavities.
The device is a single-component light-curable dental restorative material that contains a fluoride releasing agent used for the restoration of all class cavities. Kerr Compomer is available in Vita® shading in a Unidose delivery system.
The provided text is a 510(k) summary for the Kerr Compomer dental restorative material, submitted to the FDA in 1997. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, detailed study results, or the other specific points requested in your prompt.
The 510(k) summary focuses on establishing substantial equivalence based on the device description, intended use, and comparison to legally marketed predicate devices (Dyract, Dentsply and Compoglass, Vivadent). It states, "The dental restorative material is substantially equivalent to several other legally marketed devices in the United States. The dental restorative materials marketed by Dentsply and Vivadent function in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center."
To answer your prompt, specific performance data (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, etc.) would typically be found in a separate, more detailed technical report or study submission, not in this summary document.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document only confirms that the device was considered "substantially equivalent" for marketing purposes, not the detailed scientific studies usually associated with your questions.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.