# K082553: Rexastom Oral Ease

- Pathway: 510(k) (Traditional)
- Applicant: Rexaderm, Inc.
- Decided: Nov 21, 2008 after 79 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: 2 generations back to K983182 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013056: Gelclair Concentrated Oral Gel, Sinclair Pharmaceuticals, Ltd. (2001) Summary page 1.
- K023155: Aloclair Oral Rinse, Sinclair Pharmaceuticals, Ltd. (2002) Summary page 1.

## Indications for use
RexaStom Oral Ease has a mechanical barrier action indicated for the temporary relief of pain by adhering to the mucosal surface of the mouth, covering and soothing oral lesions of various etiologies. The lesions include oral mucositis resulting from chemo- or radiation therapy, stomatitis, irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, aphthous ulcers, or other diseases or conditions of the oral mucous surfaces.

Source page: https://510kreport.com/device/K082553
Methodology: https://510kreport.com/methodology