# K011009: White Mta Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International
- Decided: May 2, 2001 after 28 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
No predicates in its family tree.
57 later devices descend from it; 6 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K063422: Bioaggregate (2006), 38 descendants of its own
- K080917: Iroot SP (2008), 37 descendants of its own
- K073218: Mta Advanced Material (2008), 22 descendants of its own
- K080203: Mta Root Canal Sealer (2008), 21 descendants of its own
- K112046: Mta Angelus (2012), 15 descendants of its own

Source page: https://510kreport.com/device/K011009
Methodology: https://510kreport.com/methodology