# K103054: Periopatch

- Pathway: 510(k) (Traditional)
- Applicant: Izun Pharmaceuticals Corporation
- Decided: Feb 7, 2011 after 115 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110750: Periopatch (2011), 2 descendants of its own
- K211851: Ora-Aid (2022), 1 descendant of its own
- K253816: MuCover (proposed name) Oral Wound Dressing (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K103054
Methodology: https://510kreport.com/methodology