# K063148: Sock IT! Oral Pain Gel

- Pathway: 510(k) (Traditional)
- Applicant: Merlin Group Dba Mcmerlin Dental Company
- Decided: Jan 17, 2007 after 93 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: 2 generations back to K953423 (1995). 5 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933741: Carrasyn Oral Wound Dressing, Carrington Laboratories, Inc. (1994) Summary page 1.
- K953423: Casrrasyn Oral Wound Dressing, Carrington Laboratories, Inc. (1995) Summary page 1.
- K964852: Radiacare Oral Wound Rinse, Carrington Laboratories, Inc. (1997) Summary page 1.
- K983182: Aloe Therapy Oral Rinse, Carrington Laboratories, Inc. (1998) Summary page 1.
- K012126: The Salicept Oral Patch, Carrington Laboratories, Inc. (2001) Summary page 1.

## Most influential descendants
- K210211: PuraStat-OM (2021), 4 descendants of its own
- K213552: PuraStat-RM (2022), 3 descendants of its own
- K242634: PuraStat (2025), 2 descendants of its own
- K253923: PuraStat (2026), 1 descendant of its own
- K260120: NaturaJel™ Oral Wound Care Kit (2026), 0 descendants of its own

## Indications for use
This product manages the pain in all types 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 and contamination, It provides the moist wound environment required for optimal wound healing. Manages pain of, for example: - All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa - Canker sores and cold sores - Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders - Soft tissue pain from orthodontics - Aphthous ulcers - Extraction site pain - Oral mucositis and stomatitis - Irritation and pain following tooth scaling and prophylaxis This product manages the pain in all types 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 and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain of, for example: - All types of oral wounds, mouth sores, injuries and ulcers of the mouth - Canker sores and cold sores - Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders - Aphthous ulcers - Irritation and discomfort from ill-fitting dentures

Source page: https://510kreport.com/device/K063148
Methodology: https://510kreport.com/methodology