# K112078: Endocem Mta (Mineral Trioxide Aggregate)

- Pathway: 510(k) (Traditional)
- Applicant: Maruchi
- Decided: Mar 19, 2012 after 242 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: 3 generations back to K964174 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981620: Mta Material II, Dentsply Intl. (1998) Summary page 1.

## Most influential descendants
- K133042: Endocem ZR (2014), 0 descendants of its own

## Indications for use
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 As a consequence of internal resorption As a pulp capping material For the filling of pulpotomy of deciduous tooth

Source page: https://510kreport.com/device/K112078
Methodology: https://510kreport.com/methodology