Search Results

"Dimer Dual Cure Temporary Resin Cement" is indicated for the temporary cementation of provisional restorations such as crowns and Bridges, inlays and onlays, Maryland bridges, veneers or for the temporary cementation of permanent dental restorations.

"Dimer Dual Cure Permanent Resin Cement" is indicated for the final cementation of implant prostheses, crowns and bridges, inlays and onlays, Maryland bridges, veneers, pins and posts and also periodontal splinting.

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a dental cement. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The document primarily focuses on:

• Acknowledging the 510(k) submission for "Dimer Dual Cure Permanent Resin Cement" and "Dimer Dual Cure Temporary Resin Cement."
• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the general controls and regulations applicable to the device.
• Providing the Indications for Use for both permanent and temporary resin cements.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study from this document, as that information is not present.

Ask a specific question about this device

A radiopaque, self-cure, resin-based temporary cement that is used to lute provisional restorations such as crowns, inlays, onlays, fixed bridges, laminate veneers, etc. or to temporarily cement permanent dental restorations.
A resin-based cement designed for use with provisional restorations such as crowns, inlays, fixed bridges, etc. or for temporary cementation of permanent restorations.

A radiopaque, self-cure, resin-based temporary cement

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.

The document is a 510(k) summary for a dental temporary cement, outlining its intended use, classification, and substantial equivalence to predicate devices. It does not contain details about specific performance metrics or clinical study results.

Ask a specific question about this device