# K140247: Mta Fillapex

- Pathway: 510(k) (Special)
- Applicant: Angelus Industria DE Productos Odontologicos SA
- Decided: Apr 25, 2014 after 85 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: 5 generations back to K011009 (2001). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113568: Mta-Fillapex, Paxmed International (2012) Summary page 2.
- K010940: Sealapex 4, Sybron Dental Specialties, Inc. (2001) Summary page 2.

## Most influential descendants
- K172701: Bio-C Sealer (2018), 1 descendant of its own
- K190537: BIO-C Sealer Ion+ (2019), 0 descendants of its own

## Indications for use
MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.

Source page: https://510kreport.com/device/K140247
Methodology: https://510kreport.com/methodology