# K981620: Mta Material II

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jul 31, 1998 after 86 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 K964174 (1997). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964174: Mineral Trioxide Aggregate (Mta), Tulsa Dental Products, Ltd. (1997) Summary page 1.
- K980332: Mta Material, Dentsply Intl. (1998) Summary page 1.

## Most influential descendants
- K142178: Proroot Mta White, Proroot Mta Gray (2015), 3 descendants of its own
- K112078: Endocem Mta (Mineral Trioxide Aggregate) (2012), 1 descendant of its own
- K252285: Well-Root PT (2025), 0 descendants of its own
- K222992: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material (2022), 0 descendants of its own
- K162661: SavDenTM MTA Root Canal Filling Materials (2017), 0 descendants of its own

## Indications for use
MTA MATERIAL Il is indicated for use as a root end filling material.

Source page: https://510kreport.com/device/K981620
Methodology: https://510kreport.com/methodology