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For the temporary cementation of provisional restorations; temporary cementation of permanent restorations during the trial phase. The product has been designed to remain in the mouth for up to 4 weeks.

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The provided text is a 510(k) premarket notification letter from the FDA for a dental cement called "Systemp.cem". It primarily discusses the substantial equivalence determination for the device, its classification, and regulatory requirements.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

Therefore, I cannot provide the requested table and study details.

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For the fabrication of temporary crowns and bridges until the permanent restoration can be delivered.

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The provided text is a 510(k) substantial equivalence determination letter from the FDA for a dental device called "Systemp.c&b Plus" (K042820). This type of document confirms that a new device is as safe and effective as a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for a medical device AI/ML model.

Instead, it's a regulatory approval letter for a temporary crown and bridge resin, a material used in dentistry, not a diagnostic or AI-powered device. The content focuses on regulatory compliance, legal marketing, and general controls provisions of the Act.

Therefore, I cannot provide the requested information based on the provided text. The questions are relevant to the evaluation of AI/ML medical devices, which this document does not describe.

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