# K170175: Endoseal Mta

- Pathway: 510(k) (Traditional)
- Applicant: Maruchi
- Decided: Feb 26, 2018 after 403 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: 7 generations back to K990131 (1999). 39 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133054: Endoseal, Maruchi (2014) Summary page 4.
- K113568: Mta-Fillapex, Paxmed International (2012) Summary page 4.
- K080917: Iroot SP, Innovative Bioceramix, Inc. (2008) Summary page 4.

## Most influential descendants
- 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
- K212563: CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid (2022), 0 descendants of its own

## Indications for use
Permanent obturation of the root canal following vital pulp-extirpation Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

Source page: https://510kreport.com/device/K170175
Methodology: https://510kreport.com/methodology