# K261404: UltraEZ

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Apr 30, 2026 after 1 day
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- 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 K061438 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061438: Ultraez Desensitizing Gel, Ultradent Products, Inc. (2007) Summary page 5.

## Indications for use
UltraEZ desensitizing gel helps relieve and prevent tooth sensitivity from whitening treatments. It also helps with sensitivity to cold food or drinks caused by exposed roots from gum recession or worn-down teeth. UltraEZ gel is for adults with good oral health.

Source page: https://510kreport.com/device/K261404
Methodology: https://510kreport.com/methodology