Search Results

Dentin and Enamel adhesive for use with resin based restorative materials.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental adhesive named "STAE." It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain any information about:

• Acceptance criteria or reported device performance in a table format.
• Sample sizes for test sets or their data provenance.
• Number or qualifications of experts used for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets.
• How ground truth for training sets was established.

The letter is purely a regulatory approval document and does not detail the technical studies or performance data that would have been submitted as part of the 510(k) application.

Ask a specific question about this device