# K061438: Ultraez Desensitizing Gel

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jun 12, 2007 after 384 days
- 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
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cosmedent Tooth Desensitizer: named in the summary without a submission number
- (no number) Protect Tooth Desensitizer: named in the summary without a submission number

## Most influential descendants
- K082594: Remesense (2009), 3 descendants of its own
- K120176: Senzzzzz Away (2012), 2 descendants of its own
- K122708: Remesense for Sensitive Teeth (2013), 1 descendant of its own
- K261404: UltraEZ (2026), 0 descendants of its own
- K222891: Dental Desensitizer (2023), 0 descendants of its own

## Indications for use
The UltraEZ Desensitizing Gel provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

Source page: https://510kreport.com/device/K061438
Methodology: https://510kreport.com/methodology