(88 days)
Point 4 Modified is a dental composite restorative material intended to be used 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 does not contain information about acceptance criteria, device performance details, or any study conducted to prove the device meets acceptance criteria. The document is a 510(k) summary for a dental composite restorative material, Point 4 Modified, and largely focuses on its intended use, device description, and substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details 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.