(48 days)
- A dentin bonding agent used with direct filling materials that include but may not be limited to, composite resins, resin modified glass ionomers or compomers, etc.
- A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, lamin veneers, either resin or porcelain, etc.
- Treatment of hypersensitive areas of exposed root surfaces.
- A cavity sealant applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy inlays or onlays, etc.
"TO BE NAMED" may be described as a single-bottle, light cured, dentin-bonding system especially formulated for use with resin composite restorative materials. The material is self-etching and does not require acid etching of tooth surfaces. It will also reliably bond to properly prepared porcelain or alloy surfaces that are free of contamination.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details. The document is a 510(k) summary and an FDA clearance letter for a dental bonding agent, primarily focusing on its intended use, classification, and substantial equivalence to previously marketed devices. It does not contain the kind of technical study details you are requesting.
§ 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.