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G-BOND PLUS is one-bottle typed light-cured bonding agent, and intended to be used for bonding light-cured composite resin to tooth.

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The provided document is an FDA 510(k) clearance letter for a dental bonding agent named "G-BOND PLUS." This document focuses on the regulatory authorization for marketing the device based on its substantial equivalence to a predicate device. It does not contain information regarding acceptance criteria for a specific performance study, the device's reported performance against such criteria, or details of a study that would demonstrate such performance (e.g., sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies with AI).

Therefore, I cannot answer your request based on the provided text. This document is a regulatory approval notice, not a scientific study report.

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This product is a light-cured dentin bonding agent to provide effective bonding to resin composite restorative materials.

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This document is a 510(k) clearance letter from the FDA for a dental bonding agent called "G-BOND." It does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is strictly about the regulatory clearance of a medical device (a resin tooth bonding agent) and does not involve AI or any performance study as described in your request.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device