# K102575: Ortho Mta (Mineral Trioxide Aggregate)

- Pathway: 510(k) (Traditional)
- Applicant: Do Co., Ltd.
- Decided: Oct 29, 2010 after 51 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 K011009 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011009: White Mta Material, Dentsply International (2001)

## Most influential descendants
- K132825: Retromta-Orthomta II (2014), 1 descendant of its own
- K230797: SmartMTA Capsule (2023), 0 descendants of its own

## Indications for use
Orthograde root canal filling material Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal resorption Repair of root canals as an apical plug during apexification Root end filling Pulp capping

Source page: https://510kreport.com/device/K102575
Methodology: https://510kreport.com/methodology