# K133054: Endoseal

- Pathway: 510(k) (Traditional)
- Applicant: Maruchi
- Decided: May 12, 2014 after 227 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.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K120078: Healix Advance BR Anchor, Depuy Mitek Inc., Johnson and Johnson Company (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K201799: CleaniCal (2021), 2 descendants of its own
- K202015: White ENDOSEAL MTA (2021), 1 descendant of its own
- K231480: Bright MTA Sealer Plus (2023), 0 descendants of its own
- K221811: Vista BC Sealer (2022), 0 descendants of its own

## Indications for use
Repair of perforation Root canal filling

Source page: https://510kreport.com/device/K133054
Methodology: https://510kreport.com/methodology