# K183436: OraCure

- Pathway: 510(k) (Traditional)
- Applicant: Tbm Corporation
- Decided: Sep 18, 2019 after 281 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). 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)
- K070842: Ulceloocin Oral Ulcer Patch, Sunshine International Group, Inc. (2007) Summary page 4.

## Most influential descendants
- K260126: Curajel™ Oral Gel (2026), 0 descendants of its own

## Indications for use
OraCure® 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/K183436
Methodology: https://510kreport.com/methodology