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• Class I to V restorations
• Base in class I and II cavities
• Reconstruction of traumatically damaged anteriors
• Facetting of discoloured anteriors
• Correction of shape and shade for improved aesthetic appearance
• Locking, splinting of loose anteriors
• Repairing veneers, small enamel defects and temporary C&B-materials
• Extended fissure sealing
• Restoration of deciduous teeth
• Core build-up
• Composite inlays

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental restoration material called "VisCalor." It outlines the device name, regulation number, class, product code, and indications for use.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in your prompt regarding a study proving a device meets acceptance criteria.

Therefore, I cannot fulfill your request using the provided input.

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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 text is a 510(k) clearance letter for a dental device called VisCalor Bulk. It contains information related to the device's indications for use and regulatory classification. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information. The text is a regulatory document and not a clinical study report or technical specification document detailing performance metrics.

Ask a specific question about this device