# K210211: PuraStat-OM

- Pathway: 510(k) (Traditional)
- Applicant: 3-D Matrix, Inc.
- Decided: Oct 8, 2021 after 254 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.
4 later devices descend from it; 1 cites it directly.
0 of 11 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.

## Most influential descendants
- 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
- K261504: PuraStat-RM (2026), 0 descendants of its own

## Indications for use
PuraStat-OM adheres to oral tissue and forms a protective barrier over the wound to prevent further irritation and contamination. It provides a 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 (may be caused by chemotherapy or radiotherapy)

Source page: https://510kreport.com/device/K210211
Methodology: https://510kreport.com/methodology