(27 days)
MTA MATERIAL is indicated for the repair of root canals as an apical plug during Apexification, and repair of Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption.
MTA MATERIAL is identical to K964174, Mineral Trioxide Aggregate (found substantially equivalent February 10, 1997). This submission is for a new intended use. MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.
This 510(k) submission (K980332) for "MTA MATERIAL" describes a device that is identical in composition to a previously cleared device (K964174, Mineral Trioxide Aggregate) but is seeking clearance for new intended uses. Therefore, the acceptance criteria and performance data presented relate to the suitability of the existing material for these new indications.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a new intended use of an identical material, the acceptance criteria are implicitly tied to demonstrating the effectiveness of the material for the specified new indications through various in-vitro and animal studies. There aren't explicit quantifiable "acceptance criteria" presented in the manner of a typical performance study for a novel device, but rather a demonstration of biological and functional performance in relevant models.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| For Non-Apical Root Perforation Repair: | |
| Ability to effectively seal non-apical (lateral) root perforations, demonstrating less leakage than existing materials. | Study: In-vitro extracted tooth model (dye penetration study) comparing MTA MATERIAL to IRM® filling material and amalgam. |
| Performance: MTA MATERIAL showed the least degree of dye leakage. Significantly less leakage (p |
§ 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.