# K253816: MuCover (proposed name) Oral Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: MoleculeX Co., Ltd.
- Decided: May 21, 2026 after 174 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 K103054 (2011). 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)
- K211851: Ora-Aid, Tbm Corporation (2022) Summary page 5.

## Indications for use
Oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery. Oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.

Source page: https://510kreport.com/device/K253816
Methodology: https://510kreport.com/methodology