Search Results

Adhesive cementation of indirect meal-free restorations (inlays, onlays, crowns, bridges or of metal free posts with dual or self curing composites.

Direct restorations and core build-ups with dual and self curing composites.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental bonding agent, AdheSE® DC Activator, indicating it has been deemed substantially equivalent to a legally marketed predicate device.

It primarily details:

• The device name and regulation number.
• The date of clearance.
• The regulatory classification (Class II).
• General information about FDA regulations and compliance.
• The intended indications for use of the device.

There is no mention of specific acceptance criteria, performance metrics, a study design, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

Ask a specific question about this device