# K980332: Mta Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Feb 24, 1998 after 27 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964174 (1997). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964174: Mineral Trioxide Aggregate (Mta), Tulsa Dental Products, Ltd. (1997) Summary page 1.

## Most influential descendants
- K981620: Mta Material II (1998), 6 descendants of its own
- K142178: Proroot Mta White, Proroot Mta Gray (2015), 3 descendants of its own
- K112078: Endocem Mta (Mineral Trioxide Aggregate) (2012), 1 descendant of its own
- K252285: Well-Root PT (2025), 0 descendants of its own
- K222992: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K980332
Methodology: https://510kreport.com/methodology