# K122892: MTA2 Root and Pulp Materials

- Pathway: 510(k) (Traditional)
- Applicant: Avalon Biomed, Inc.
- Decided: Dec 11, 2012 after 82 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: 3 generations back to K011009 (2001). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011009: White Mta Material, Dentsply International (2001) Summary page 1.
- K080203: Mta Root Canal Sealer, Dentsply Interntional (2008) Summary page 1.

## Most influential descendants
- K140955: MTA2.1 Material (2014), 3 descendants of its own
- K161239: MTA2.2 Material (2016), 2 descendants of its own
- K181917: MTA2.3 Materials (2019), 1 descendant of its own
- K241457: Vista BC Putty (2024), 0 descendants of its own

## Indications for use
The MTA2 ROOT AND PULP MATERIALS are intended for use in dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.

Source page: https://510kreport.com/device/K122892
Methodology: https://510kreport.com/methodology