# K080203: Mta Root Canal Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Interntional
- Decided: Mar 26, 2008 after 58 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.
21 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073218: Mta Advanced Material, Dentsply Interntional (2008) Summary page 1.

## Most influential descendants
- K112046: Mta Angelus (2012), 15 descendants of its own
- K113568: Mta-Fillapex (2012), 12 descendants of its own
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K122892: MTA2 Root and Pulp Materials (2012), 4 descendants of its own
- K140955: MTA2.1 Material (2014), 3 descendants of its own

## Indications for use
MTA ROOT CANAL SEALER is indicated for use for the permanent sealing of root canals of teeth and may be used in combination with root canal obturation materials.

Source page: https://510kreport.com/device/K080203
Methodology: https://510kreport.com/methodology