# K181917: MTA2.3 Materials

- Pathway: 510(k) (Traditional)
- Applicant: NuSmile, Ltd.
- Decided: Jan 11, 2019 after 178 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: 6 generations back to K011009 (2001). 6 ancestors in all.
1 later device descends 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)
- K161239: MTA2.2 Material, Avalon Biomed, Inc. (2016) Summary page 4.

## Most influential descendants
- K241457: Vista BC Putty (2024), 0 descendants of its own

## Indications for use
The MTA2.3 ROOT & PULP MATERIALS are intended for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.

Source page: https://510kreport.com/device/K181917
Methodology: https://510kreport.com/methodology