(43 days)
Prodigy 2 is a dental composite restorative material intended to be used in Class I and Class II cavity situations. However, Prodigy 2 may also be used in all classes of cavities, wherever an additional resistance to pack is deemed necessary.
The device is a visible light cured dental composite restorative material. Due to the material's unique handling characteristics, Prodigy 2 is suggested for use in Class I and Class II cavity situations. However, Prodigy 2 may also be used in all classes of cavities, wherever an additional resistance to pack is deemed necessary.
This document is a 510(k) summary for a dental composite restorative material called "Prodigy 2." It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the way a medical device typically would for diagnostic or therapeutic efficacy. This submission is for a material, not a diagnostic or AI-driven device.
Therefore, I cannot provide the requested information. The provided text is a regulatory filing for a dental restorative material, focusing on its substantial equivalence to existing products rather than performance metrics against specific acceptance criteria for a diagnostic or AI device.
§ 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.