# K212229: White Endoseal MTA

- Pathway: 510(k) (Special)
- Applicant: Maruchi
- Decided: Aug 13, 2021 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
Longest line of descent: 9 generations back to K990131 (1999). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202015: White ENDOSEAL MTA, Maruchi (2021) Summary page 4.

## Indications for use
Permanent root canal obturation

Source page: https://510kreport.com/device/K212229
Methodology: https://510kreport.com/methodology