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Renamel Pack should be used for placement of posterior restorations. It can be used as the total restoration or in a layering technique to establish excellent proximal contact prior to overlay of a finishing material. Use for: Posterior composite restoration. Contact development in posterior restoration prior to occlusal overlay of more polishable materials.

Renamel Pack Composite is a system consisting of light cured composite restorative materials.

The provided text is a Food and Drug Administration (FDA) clearance letter for the Renamel Pack device (K993659). This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically provided in a study report.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device already on the market, not on a new, comprehensive performance study with specific acceptance criteria that would typically be described in the context of proving a medical device meets performance standards.

Therefore, I cannot extract the requested information from the provided document. The 510(k) clearance process focuses on demonstrating equivalence to a previously cleared device, not necessarily on new clinical performance data with detailed acceptance criteria as one might find for a novel device or a PMA submission.

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