(90 days)
- Base under Class I and II direct restorations
- Pit and fissure sealant
- Class III and V restorations
- Repair of resin, porcelain and acrylic temporary materials
- Liner under direct restorative materials
Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent enabling up to a depth of 3~5mm at a time. Jet Flow Bulk is packaged in disposable tips and two syringes that include restorative materials. The shades offered with Jet Flow Bulk are Universal(U), Dentin(D), A1, A2, A3. Jet Flow Bulk contains bisGMA, UDMA, bisEMA. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.053 to 6.76 microns and silica with a particle size range of 0.04 to 0.452 um. The inorganic filler loading is approximately 35.6 vol.% (61.0wt.%).
The document provided is a 510(k) premarket notification clearance letter for a dental device, "Jet Flow Bulk." It does not contain information about an AI/ML device or its performance characteristics in the context of a clinical study or acceptance criteria related to software performance. The acceptance criteria and "study" described in the document are for material properties and biocompatibility of a dental resin, not for an AI algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for "the device" as requested by the user, because the provided text is about a physical dental material and not an AI-powered medical 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.