(64 days)
Premise Flowable 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 nonstress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
Premise Flowable is a nano-filled, light-cure, resin restorative material dispensed in a syringe with single-use tips. Premise Flowable uses pre-polymerized filler and nanofillers combined with proven Point 4 technology to deliver strength and durability.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a dental restorative material called "Premise Flowable," outlining its intended use, description, and claiming substantial equivalence to predicate devices, but it does not detail specific performance studies or acceptance criteria for those studies.
§ 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.