# K063856: EZ-Fill Xpress Epoxy Root Canal Cement System

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systems, Inc.
- Decided: Feb 6, 2007 after 40 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: 2 generations back to K960548 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992727: The BI-Directional Spiral & Epoxy Root Canal Cement System, Mds (2000) Summary page 1.
- K960548: AH Plus Root Canal Sealer, Dentsply Intl. (1996) Summary page 1.

## Indications for use
The EZ-Fill® Xpress Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.

Source page: https://510kreport.com/device/K063856
Methodology: https://510kreport.com/methodology