# K132825: Retromta-Orthomta II

- Pathway: 510(k) (Traditional)
- Applicant: Biomta
- Decided: Apr 10, 2014 after 213 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: 2 generations back to K011009 (2001). 2 ancestors in all.
1 later device descends 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)
- K102575: Ortho Mta (Mineral Trioxide Aggregate), Do Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K230797: SmartMTA Capsule (2023), 0 descendants of its own

## Indications for use
The RetroMTA-OrthovTA His indicated for use as: - Orthograde root canal filling material - Repair of root perforations during root canal therapy(endlodontic therapy), or as a consequence of internal and external resorption. - Repair of root canals as an apical plug during apexification - Root end filling - Pulp capping

Source page: https://510kreport.com/device/K132825
Methodology: https://510kreport.com/methodology