# K211995: Sonendo Filling Material 5C

- Pathway: 510(k) (Traditional)
- Applicant: Sonendo, Inc.
- Decided: Aug 27, 2021 after 60 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 K992097 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K071106: Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill), Model 399, Ultradent Products, Inc. (2007) Summary page 4.

## Most influential descendants
- K231387: Endofill (2023), 0 descendants of its own

## Indications for use
Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.

Source page: https://510kreport.com/device/K211995
Methodology: https://510kreport.com/methodology