(79 days)
Premise Flowable Modified is a nano-filled, light cure, resin dental restorative suitable for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing area, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions and core build-ups.
Premise Flowable Modified is a medium viscosity, light-cured, nano filled, resin restorative material, dispensed in a syringe with single-use tips. It is suitable for Class I - V restorations. This nano composite technology incorporates three different fillers resulting in a flowable, yet sculptable and non-slumping material.
The provided text is a 510(k) summary for a dental restorative material. It does not contain information about acceptance criteria, device performance metrics, or any studies involving a test set, expert ground truth, or human-AI comparison.
The document discusses the device's name, description, intended use, and claims of substantial equivalence to a legally marketed predicate device (Premise Flowable by Kerr Corporation). It also includes the FDA's clearance letter.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study proving the device meets them, as that information is not present in the provided text. This document is a regulatory submission summary, not a scientific study report.
§ 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.