(22 days)
EndoREZ is used for permanent obturation of root canals of teeth of the secondary dentition with or without the aid of obturation points. It is easily delivered to the canals with a small NaviTip. When mixed and delivered in a syringe, the sealer can be used for the single cone technique or for the continuous wave condensation technique.
Not Found
This is a Food and Drug Administration (FDA) 510(k) clearance letter for a dental device called EndoREZ, a root canal filling resin. The document states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain specific acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study information requested in your prompt (sample sizes, ground truth establishment, expert qualifications, etc.).
Therefore, I cannot provide the requested information about acceptance criteria and study details based on the provided text. The letter is purely an administrative clearance document.
§ 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.