(211 days)
- A root end filling material.
- For the repair of root canals as an apical plug during apexification.
- For repair of root perforations during root canal therapy or as a consequence of internal resorption.
- As a pulp capping material.
- Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations.
SavDen™ MTA powder consists of fine, hydrophilic particles that set in the presence of water. Hydration of the powder creates a colloidal gel that is solidified to form an impermeable barrier that fully cures over a four-week period.
This document describes the marketing authorization for a medical device and is not a study that uses an AI/ML powered device, therefore the information required to analyze such a device is not present in the 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.