# K072082: Gumease Dental Mouthpiece

- Pathway: 510(k) (Traditional)
- Applicant: Biomedevice, Ltd.
- Decided: Nov 5, 2007 after 98 days
- Product code: KKO (Ring, Teething, Fluid-Filled)
- Device class: 2
- Regulation: 21 CFR 872.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963666 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963666: Instant Cold Pack, Kick Ice, Inc. (1996) Summary page 1.
- K970399: Kwik Kold Peri Cold Pack (Catalog Number TBD), Allegiance Healthcare Corp. (1997) Summary page 1.
- K002066: Freezer Teether, Cool Baby, Inc. (2000) Summary page 1.

## Indications for use
The gumEase® dental mouthpiece provides temporary relief from oral discomfort resulting from dental work, brace pain, denture irritation, post surgical pain or minor oral trauma.

Source page: https://510kreport.com/device/K072082
Methodology: https://510kreport.com/methodology