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Anterior restorations (Class III, IV)

Tooth Neck restorations (Class V, e.g. cervical caries, root erosion, wedge-shaped defects)

Restorations in the posterior region (Class I and II)

Direct Veneers

Corrections of tooth positions and tooth shape (e.g. diastema closure, closure of interdental "black triangles," lengthening of the incisal edge

Not Found

The provided text is a 510(k) clearance letter from the FDA for the device "EMPRESS® DIRECT". This document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to a predicate device.

Crucially, this document does not contain any information about acceptance criteria, the study design, or performance metrics. It's a regulatory approval letter, not a scientific study report.

Therefore, I cannot provide the requested information. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study.
7. The type of ground truth used.
8. The sample size for a training set.
9. How the ground truth for the training set was established.

This document indicates the device's intended uses (Indications For Use) and its product code (EBF, which is associated with tooth restorative material, resin, for permanent use). To find the kind of information requested, one would typically need to consult a clinical study report submitted as part of the 510(k) application, which is not included here.

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