# K992097: Endorez

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Oct 26, 1999 after 127 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071106: Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill), Model 399 (2007), 2 descendants of its own
- K011748: First Fill R.C.S. (2001), 2 descendants of its own
- K211995: Sonendo Filling Material 5C (2021), 1 descendant of its own
- K231387: Endofill (2023), 0 descendants of its own
- K060889: SE Epiphany Root Canal Sealant, Model N59SE (2006), 0 descendants of its own

## Indications for use
EndoREZ is used for permanent obturation of root canals of teeth of the secondary dentition with or without the aid of obturation points. It is easily delivered to the canals with a small Endo-Eze tip. When mixed and delivered in a syringe, the sealer can be placed close to the apex of the root, eliminating or minimizing air entrapment.

Source page: https://510kreport.com/device/K992097
Methodology: https://510kreport.com/methodology