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1. 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.
2. 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.
3. Treatment of hypersensitive areas of exposed root surfaces.
4. 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.

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