(19 days)
The intended use of Prodigy 4 is for use in all classes of cavities.
The device is a micro-hybrid light cured resin-based dental restorative which contains approximately 79% by weight (59% by volume) inorganic filler but with a particle size nearly half that of Kerr's Herculite XRV and Prodigy. This breakthrough in filler technology provides a higher, longer-lasting polish similar to a microfill, without any negative effects to the physical properties.
The provided text is a 510(k) summary for a dental composite restorative material called "Prodigy 4." It details the device's description, intended use, and its claim of substantial equivalence to existing legally marketed devices. However, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) summary focuses on demonstrating substantial equivalence, which is a regulatory pathway for medical devices. For this type of device, substantial equivalence is primarily established by comparing its physical and chemical properties, intended use, and performance characteristics to those of predicate devices already on the market. It does not typically require the submission of clinical study data with acceptance criteria in the same way a novel high-risk device might.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them because this information is not present in the provided text.
§ 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.