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Found 3 results
510(k) Data Aggregation
(174 days)
- Direct bonding of restorative materials
- Bonding of dual-cured core build up composites
- Adhesive cementation of indirect restorations
- Priming of adherent surface of indirect restorations
- Intraoral repair of fractured restorations
- Treatment of hypersensitive teeth
- Sealing of tooth preparation (cavity or abutment) for indirect restorations
- Treatment of exposed root surfaces
- Micro-invasive treatment and infiltration of non-cavitated non-carious enamel lesions
- Post cementation
G-BOND Universal is a one component, light-cured bonding agent, which can also be used for micro-invasive treatment and infiltration of non-cavitated non-carious enamel lesions, available in a 5 mL liquid bottle or 0.1 mL unit dose.
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(29 days)
G-BOND PLUS is one-bottle typed light-cured bonding agent, and intended to be used for bonding light-cured composite resin to tooth.
Not Found
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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(27 days)
This product is a light-cured dentin bonding agent to provide effective bonding to resin composite restorative materials.
Not Found
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.
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