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Flex Span Temporary Crown & Bridge Material is intended to be used to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Flex Span Temporary Crown & Bridge Material is to be used on dental patients in a dental office environment. Flexspan has the capability of being dual-cured, ic, visible light cure and/or self-cured. The optional light curing ability will give the dentist a choice of not waiting too long for the material to fully cure, if there is a need to fasten the hardening of the material.

The provided text does not contain information regarding an acceptance criteria table or the results of a study to prove device performance. The document is a 510(k) summary and FDA clearance letter for a dental material, not a clinical study report. Therefore, I cannot generate the requested table and study details.

The 510(k) summary states that "Cytotoxicity test has been performed" and that "all the ingredients used in the formulation are widely used in dental industry and in our own composite compositions, which are known to be safe and effective." However, it does not provide specific acceptance criteria, test results, sample sizes, or details about the ground truth or expert involvement as requested.

The FDA letter confirms that the device is substantially equivalent to a predicate device (Temphase, K020092), meaning it has the same intended use and similar technological characteristics, and that it is as safe and effective as the predicate. This substantial equivalence determination is the basis for its market clearance, but it does not involve the detailed criteria or study types requested in your prompt for an AI-based medical device.

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