# K071106: Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill), Model 399

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: May 8, 2007 after 19 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: 1 generation back to K992097 (1999). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992097: Endorez, Ultradent Products, Inc. (1999) Summary page 1.
- K042756: Endorez, Ultradent Products, Inc. (2004) Summary page 1.

## Most influential descendants
- K211995: Sonendo Filling Material 5C (2021), 1 descendant of its own
- K231387: Endofill (2023), 0 descendants of its own

## Indications for use
EndoREZ is designed to be used with EndoREZ Points and/or gutta percha for the filling of cleaned and shaped root canals. EndoREZ, in conjunction with a master cone and accessory cones (as needed), provides optimum sealing. Although EndoREZ Points are recommended, EndoREZ may be used with all conventional endodontic obturation techniques.

Source page: https://510kreport.com/device/K071106
Methodology: https://510kreport.com/methodology