# K191987: Orapeutic

- Pathway: 510(k) (Traditional)
- Applicant: Forward Science
- Decided: Nov 27, 2019 after 125 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063148: Sock IT! Oral Pain Gel, Merlin Group Dba Mcmerlin Dental Company (2007) Summary page 4.

## Indications for use
Orapeutic™ Oral Pain Gel manages the pain of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation & contamination. Orapeutic™ Oral Pain Gel also maintains a moist wound environment.

Source page: https://510kreport.com/device/K191987
Methodology: https://510kreport.com/methodology