# K260120: NaturaJel™ Oral Wound Care Kit

- Pathway: 510(k) (Traditional)
- Applicant: HCS Innovation, LLC
- Decided: Aug 5, 2026 after 202 days
- Product code: OLR (Oral Wound Dressing)
- Device class: U
- 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 K953423 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063148: Sock IT! Oral Pain Gel, Merlin Group Dba Mcmerlin Dental Company (2007) Summary page 5.

## Indications for use
NaturaJel adheres to oral mucosal tissue and forms a protective barrier over wounds or ulcers to prevent further irritation and contamination. It provides a moist wound environment required for optimal healing. NaturaJel manages pain associated with: * Oral mucosal wounds, sores, injuries, and ulcers * Canker sores and cold sores * Irritation from orthodontic appliances (braces, brackets, expanders), dentures, and partials * Soft tissue pain from orthodontics, aphthous ulcers, and extraction sites

Source page: https://510kreport.com/device/K260120
Methodology: https://510kreport.com/methodology