# K213757: Endocem MTA Premixed Regular

- Pathway: 510(k) (Traditional)
- Applicant: Maruchi
- Decided: Feb 14, 2023 after 441 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: 10 generations back to K990131 (1999). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082943: Iroot BP, Model Irbp 4609, Innovative Bioceramix, Inc. (2009) Summary page 4.
- K102867: Iroot FS, Innovative Bioceramix, Inc. (2010) Summary page 4.

## Indications for use
The product is used for indirect pulp capping, direct pulp capping, root end filling and Repair of perforation.

Source page: https://510kreport.com/device/K213757
Methodology: https://510kreport.com/methodology