Search Results

EndoSeal is easily delivered to the canals with the Endo-Eze 31 gauge tip. When mixed and delivered with the SpaTwist System, the sealer can be placed directly, to the bottom of the roct and is-filled from the borcom up, eliminating air entrapment. Using Spalvist with the Endo-Ene 31 gauge tip or capillary tip eliminates the need for gutta percha points.

Not Found

This document is an FDA 510(k) clearance letter for a dental device called "Endo-Seal". It does not describe acceptance criteria for a study, nor does it present device performance data that would allow me to populate the requested table or answer the specific questions about a study's methodology.

The document states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This is a regulatory determination based on comparison to existing devices, not typically on a new clinical study with specific acceptance criteria and performance metrics described in the way you've outlined.

Therefore, I cannot provide the requested information from this document. I would need a different type of document, such as a clinical study report or a premarket approval (PMA) application summary, to answer your questions.

Ask a specific question about this device