(35 days)
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.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.