# K193336: Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Synedgen, Inc.
- Decided: May 27, 2020 after 177 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
Synvaza manages the pain in many 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 associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers; aphthous ulcers.

Source page: https://510kreport.com/device/K193336
Methodology: https://510kreport.com/methodology