# K131396: Wired Mouth Protector (WMP)

- Pathway: 510(k) (Traditional)
- Applicant: Elba Laboratories, Inc.
- Decided: Sep 30, 2013 after 138 days
- Product code: PFL (Intraoral, Dental Foam Protector)
- Device class: 1
- Regulation: 21 CFR 872.6890
- 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 K924024 (1992). 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)
- K020009: Brace Eze, Udent, Inc. (2002) Summary page 1.

## Indications for use
Provides a soft barrier between wired mouth hardware and oral mucosa to help relieve discomfort for convalescing oral and maxiflofaclal surgery patients.

Source page: https://510kreport.com/device/K131396
Methodology: https://510kreport.com/methodology