# K060340: Oramagic Plus Oral Wound Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Mpm Medical., Inc.
- Decided: May 10, 2006 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: 2 generations back to K964852 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024180: Oramagicrx Oral Wound Rinse, Mpm Medical., Inc. (2003) Summary page 1.

## Indications for use
For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.

Source page: https://510kreport.com/device/K060340
Methodology: https://510kreport.com/methodology