# K020009: Brace Eze

- Pathway: 510(k) (Traditional)
- Applicant: Udent, Inc.
- Decided: Feb 11, 2002 after 40 days
- Product code: EGD (Wax, Dental, Intraoral)
- 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: 1 generation back to K924024 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924024: Ortho Wax, Heraeus Kulzer, Inc. (1992) Summary page 1.

## Most influential descendants
- K131396: Wired Mouth Protector (WMP) (2013), 0 descendants of its own

## Indications for use
Brace Eze is intended to provide relief from the discomfort and irritation to the inside of the cheek and lips caused by orthodontic brace.

Source page: https://510kreport.com/device/K020009
Methodology: https://510kreport.com/methodology