(117 days)
Used for etching of tooth enamel and/or dentin prior to the applications of bonding direct filling, repairing or enamel surface coating materials, as well as cementations such as crowns, bridges, inlays/onlays, veneers, posts, splints, orthodontic brackets, etc. made of resin composites, porcelains/ceramics, metals and their combinations. Can also be used for cleaning of restoration surfaces prior to repairing or cementation.
Phosphoric Acid Etching Gel is a flowable gel with excellent water solubility and miscibility. Using a disposable dispensing tip, Phosphoric Acid Etching Gel can be directly applied onto the tooth surface. Its color is blue, which can be identified easily on tooth or a repairing surface with contrast. Phosphoric Acid Etching Gel is used as an auxiliary material in the dental bonding procedure followed by the use of Light Cure Dental Adhesive.
The provided text is a 510(k) summary for the Phosphoric Acid Etching Gel. This document describes the device and its equivalence to a predicate device based on physical and chemical properties and technological characteristics, not on a study proving a diagnostic device meets acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment methods cannot be extracted from this document.
This document focuses on regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study for a diagnostic AI/ML device.
§ 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.