# K221428: PerioStom Dental Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Forward Science, LLC
- Decided: Dec 22, 2022 after 220 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 K972914 (1997). 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)
- K060363: Hemcon Dental Dressing, 1 Dressing, 4 Dressing, 1 Dressing, Box of 12, 4 Dressing, Box of 12, Hemcon, Inc. (2006) Summary page 4.

## Indications for use
PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

Source page: https://510kreport.com/device/K221428
Methodology: https://510kreport.com/methodology