# K964174: Mineral Trioxide Aggregate (Mta)

- Pathway: 510(k) (Traditional)
- Applicant: Tulsa Dental Products, Ltd.
- Decided: Feb 10, 1997 after 115 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
No predicates in its family tree.
8 later devices descend from it; 2 cite 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K980332: Mta Material (1998), 7 descendants of its own
- 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

## Indications for use
Indicated clinical applications include use as repair of pulpal exposures.

Source page: https://510kreport.com/device/K964174
Methodology: https://510kreport.com/methodology