# K113568: Mta-Fillapex

- Pathway: 510(k) (Traditional)
- Applicant: Paxmed International
- Decided: Aug 21, 2012 after 263 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: 4 generations back to K011009 (2001). 10 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112046: Mta Angelus, Angelus Industria DE Productos Odontologicos (2012). Cleared while this submission was under review
- K080203: Mta Root Canal Sealer, Dentsply Interntional (2008) Summary page 2.
- K820215: Improved Dycal, Dentsply Intl. (1982) Summary page 2.
- K010940: Sealapex 4, Sybron Dental Specialties, Inc. (2001) Summary page 2.
- K102163: Realseal XT Sealer, Kerr Corporation (2010) Summary page 2.
- K893794: Apexit Root Canal Sealer, Williams Dental Co., Inc. (1989) Summary page 2.
- K063237: Theracal LC, Bisco, Inc. (2006) Summary page 2.

## Most influential descendants
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K201799: CleaniCal (2021), 2 descendants of its own
- K140247: Mta Fillapex (2014), 2 descendants of its own
- K202015: White ENDOSEAL MTA (2021), 1 descendant of its own
- K172701: Bio-C Sealer (2018), 1 descendant of its own

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

Source page: https://510kreport.com/device/K113568
Methodology: https://510kreport.com/methodology