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OptiBond Solo Plus 2 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, , composite to metal, amalgam sealing, bonding composite core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns, (used in conjunction with a resin luting agent) post cementation.

The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing and bonding composite core build-up materials, and for indirect situations including veneers, onlays, inlays, crowns, and post cementation.

This document, K991808, primarily concerns the 510(k) summary for the device "OptiBond Solo Plus 2," a dental bonding agent, and its substantial equivalence to a predicate device. As such, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for a medical device (a dental bonding agent) and focuses on establishing its substantial equivalence to an existing legally marketed device. It does not detail performance studies with specific acceptance criteria as would be found for more complex diagnostic aid or AI-driven devices.

Therefore, I cannot provide the requested information.

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