(224 days)
BioRoot™ RCS is intended to be used for permanent root canal filling in combination with gutta-percha points in vital or necrotic pulp cases or after a retreatment procedure. BioRoot™ RCS is suitable for use in single cone technique or cold lateral condensation and is reserved for professional dental use only.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document is an FDA 510(k) clearance letter for the BioRoot™ RCS device, which confirms its substantial equivalence to a predicate device and lists its intended uses. It does not contain pre-market study data or performance metrics.
§ 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.