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Futurabond NR Single Dose is intended to be applied onto the interior of a prepared Futurabond NR Single Dood is internation of a restoration.

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This document is a 510(k) clearance letter from the FDA for a dental bonding agent, Futurabond NR Single Dose. It does not contain the acceptance criteria or reported device performance data. Therefore, I cannot provide the requested information.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance is based on substantial equivalence to existing devices, not necessarily a new study proving the device meets specific acceptance criteria outlined in the letter itself.

To find the information you're looking for, you would typically need to refer to the 510(k) submission document itself, or potentially a separate clinical study report if one was conducted and referenced within the submission.

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Futurabond NR is intended to be applied onto the interior of a prepared cavity of a tooth to improve retention of a restoration.

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The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Futurabond NR. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI comparative effectiveness studies.

This document is a regulatory approval notice, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device