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OptiBond All-In-One is a self-etching adhesive which combines the ingredients needed for etching, priming, and bonding into a single adhesive solution and is used for direct situations, i.e., light-cured composite and compomer restorations, composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations, lightcured or dual-cured core build-ups, and indirection situations, i.e., veneers, porcelain. composite, and metal-based inlays, onlays, crowns, bridges, endodontic posts, and cavity sealing as a pretreatment for indirect restorations.

OptiBond All-In-One self-etching adhesive combines the ingredients needed for etching, priming, and bonding into a single adhesive solution, thereby eliminating separate etching and priming steps of the bonding process. OptiBond All-In-One adhesive can be used for the bonding of both direct and indirect restorations. The advantages of using OptiBond All-In-One adhesive include simplified bonding procedures and reduced post-operative sensitivity. OptiBond All-In-One incorporates the proven GPDM adhesive technology used in Optibond Solo Plus, fillers that contain fluoride and nano-fillers. This unique technology ensures the highest level of protection against microleakage while providing high bond strengths to a variety of substrates.

The provided text is a 510(k) summary for the Optibond All-In-One resin tooth bonding agent. It describes the device, its intended use, and claims substantial equivalence to a predicate device (GC America, Inc., G-Bond).

However, the document for K060469 does not contain any information regarding acceptance criteria or a study proving the device meets specific performance criteria beyond the claim of substantial equivalence to an existing device.

The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it functions similarly and has the same intended use. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing new clinical or performance study data with specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions requested based on the provided text, as this information is not present in the document. The 510(k) process for this device focused on demonstrating equivalence, not on a new performance study with acceptance criteria.

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