# K130125: Mta Cements

- Pathway: 510(k) (Traditional)
- Applicant: S&C Polymer Silicon- Und Composite Spezialitaeten
- Decided: Jul 24, 2013 after 188 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
MTA-B: Repair of root perforations during root canal therapy Root-end filings Pulp capping Repair of root canals as an apical plug during apexilicatlon MTA-T: Repair of root perforations during root canal therapy Root-end filings Pulp capping Repair of root canals asan apical plug during apexificatlon MTA-XR: Repair of root perforations during root canal therapy Root-end filings Pulp capping Repair of maot canals as an apical plug during apexificatlon MTA-XR Flow: Repair of root perforations during root canal therapy Pulp capping Repair of root canals as an apical plug during apexification

Source page: https://510kreport.com/device/K130125
Methodology: https://510kreport.com/methodology