Search Results

Structur 3 is intended for use as:

• fabrication of temporary crowns, bridges, inlays, onlays, partial crowns, veneers and temporary posts
• fabrication of long-term temporary restorations -
• rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal

Not Found

The provided document is a 510(k) cleared by the FDA for the medical device "Structur 3", a temporary crown and bridge resin. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or performance evaluation.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for the Structur 3 device to a legally marketed predicate device.
• Regulatory information, including general controls provisions, additional controls for Class II/III devices, and compliance requirements.
• Contact information for FDA offices.
• The Indications for Use Statement for Structur 3, which outlines its intended applications (fabrication of temporary crowns, bridges, inlays, etc., and rebasing prefabricated temporary crowns).

Therefore, I cannot provide the requested information as it is not present in the given text. The request seems to be looking for details typically found in a clinical study report or a technical performance evaluation document for an AI/ML medical device, which this document is not.

Ask a specific question about this device