(74 days)
Direct composite and compomer restorations; Composite, ceramic and amalgam repairs; Cavity varnish for use with fresh amalgam; Indirect restorations-dual cure, inlays, onlays, veneers, crowns and bridges; Endodontic post cementation; and Adhesive bonding of direct amalgam restorations.
PRIME & BOND® NT™ BONDING AGENT is a one-component, no-mix visible light-curable dental bonding agent that contains fluoride. When used with the activator provided (K964525), the bonding agent may be self-cured or dual-cured.
The provided text is a 510(k) summary for a dental adhesive system, not an AI/ML device. Therefore, it does not contain information related to AI/ML specific acceptance criteria, study designs, sample sizes for test/training sets, expert ground truth adjudication, or metrics like accuracy, sensitivity, and specificity that would be used to evaluate an AI/ML device.
The document discusses the substantial equivalence of the "PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM" to predicate devices based on physical properties and biocompatibility testing. The "performance data" mentioned refers to these physical properties and biocompatibility, not AI/ML performance metrics.
As such, I cannot populate the requested table or answer the questions related to AI/ML device evaluation criteria.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.