# K012126: The Salicept Oral Patch

- Pathway: 510(k) (Traditional)
- Applicant: Carrington Laboratories, Inc.
- Decided: Oct 3, 2001 after 89 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: 1 generation back to K953423 (1995). 1 ancestor in all.
17 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953423: Casrrasyn Oral Wound Dressing, Carrington Laboratories, Inc. (1995) Summary page 5.

## Most influential descendants
- K063148: Sock IT! Oral Pain Gel (2007), 8 descendants of its own
- K210211: PuraStat-OM (2021), 4 descendants of its own
- K043587: Sucralfate and Carafate Paste Kits (2006), 4 descendants of its own
- K213552: PuraStat-RM (2022), 3 descendants of its own
- K082856: Carapaste Oral Wound Dressing (2008), 3 descendants of its own

## Indications for use
Recommended for use in tooth extraction sites and management of alveolar osteitis (dry socket). The SaliCept Oral Patch is also intended for the management of all types of oral wounds, injuries and ulcers of the oral mucosa. The Salicept Oral Patch relieves pain by adhering to and protecting affected tissues from further irritation.

Source page: https://510kreport.com/device/K012126
Methodology: https://510kreport.com/methodology