(82 days)
Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents. When used with dental bonding agents, Premier Self-Etching Bond Enhancer can be used for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up material and for bonding veneers, onlays and inlays.
Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents.
This document is a 510(k) clearance letter from the FDA for a dental bonding agent. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic devices.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size. This type of information is typically found in clinical study reports or performance data sections of 510(k) submissions, which are not included in this regulatory letter.
§ 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.