# K231387: Endofill

- Pathway: 510(k) (Traditional)
- Applicant: Lumendo AG
- Decided: Jul 10, 2023 after 59 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: 3 generations back to K992097 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211995: Sonendo Filling Material 5C, Sonendo, Inc. (2021) Summary page 4.
- K071106: Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill), Model 399, Ultradent Products, Inc. (2007) Summary page 4.

## Indications for use
Endofill (1) is indicated for the permanent obturation of root canals following root canal treatment

Source page: https://510kreport.com/device/K231387
Methodology: https://510kreport.com/methodology