(48 days)
- Restoration of minimally invasive cavity preparations (including occuusal pits and fissures)
- Conservative anterior restorations (Classes III and IV)
- Base/liner under direct restorations
- Repair of fillings and veneers
AXCEL FLOW is a visible light cure resin-based flowable restorative dental composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for class III, class IV and class V restorations. It utilizes the same resin components found in AXCEL restorative composite. The cured product has high strength and a high surface luster.
The provided text describes a 510(k) premarket notification for a dental restorative material called AXCEL FLOW. It does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or comparative effectiveness studies of an AI-powered device.
This document is a regulatory submission for a physical dental material, not a software or AI-driven diagnostic device. Therefore, it does not address the specific points requested in your prompt related to AI/software performance evaluation.
To answer your request, I need a different type of document, specifically one that describes a study evaluating an AI or software 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.