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• Class I and II posterior restorations
• Base in class I and II cavities
• Class V restorations
• Locking, splinting of loose teeth
• Repairing veneers, enamel defects and temporary C&B-materials
• Extended fissure sealing
• Restoration of deciduous teeth
• Core build-up

Not Found

The provided document is an FDA 510(k) clearance letter for a dental resin material named "GrandioSO x-tra." It confirms the device's substantial equivalence to a predicate device for specific dental restoration indications.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment. These details are typically found in the 510(k) submission itself, not in the clearance letter.

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

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