# K260126: Curajel™ Oral Gel

- Pathway: 510(k) (Traditional)
- Applicant: USpharma, Ltd.
- Decided: Jun 15, 2026 after 151 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: 4 generations back to K953423 (1995). 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)
- K183436: OraCure, Tbm Corporation (2019) Summary page 5.

## Indications for use
Curajel™ Oral Gel is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound tissue to avoid further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and ill-fitting dentures.

Source page: https://510kreport.com/device/K260126
Methodology: https://510kreport.com/methodology