(70 days)
A biocompatible, radiopaque, resin-based, self-etching, dual-cure, two-part (powder and liquid) root canal sealer that is capable of bonding with gutta percha or resinous points as well as the surrounding walls of a properly reamed and filed root canal to affect a durable seal of that canal.
A biocompatible, radiopaque, resin-based, self-etching, dual-cure, two-part (powder/liquid) root canal sealer capable of bonding with gutta percha or resinous points as well as the surrounding walls of a properly reamed and filed root canal to affect a durable seal of that canal.
The provided text is a 510(k) summary for a root canal sealer, not a study evaluating acceptance criteria for a device's performance. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It describes the device's intended use and classification but offers no performance data or study results.
§ 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.