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lonoStar Plus is intended for use as: - Restorations of non occlusion-bearing class I cavities - Semi-permanent restorations of class I and II cavities - Restorations of cervical lesions, class V cavities, root caries - Restorations of class III cavities - Restoration of deciduous teeth - Base/liner - Core build-up - Temporary restorations - Extended fissure sealing

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The provided text is an FDA 510(k) clearance letter for a dental cement called "Ionostar Plus". This document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than on detailed performance studies of an AI-powered diagnostic device.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document because it pertains to the evaluation of AI/ML or diagnostic devices, which is not what this document is about.

The document states that the Ionostar Plus is intended for use as:

• Restorations of non occlusion-bearing class I cavities
• Semi-permanent restorations of class I and II cavities
• Restorations of cervical lesions, class V cavities, root caries
• Restorations of class III cavities
• Restoration of deciduous teeth
• Base/liner
• Core build-up
• Temporary restorations
• Extended fissure sealing

The FDA determined that the device is substantially equivalent to legally marketed predicate devices, which means it has been found to be as safe and effective as a device already on the market. The letter does not include specific performance metrics, clinical study design, or evaluation of an AI algorithm.

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