| K-number | K261404 |
| Device name | UltraEZ |
| Applicant | Ultradent Products, Inc. |
| Product code | LBH |
| Device class | Class II |
| Decision date | Apr 30, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.3260 |
UltraEZ is a desensitizing gel supplied in prefilled trays for single-patient use. It relieves and prevents tooth sensitivity caused by whitening treatments or exposure to cold food and drinks from gum recession or worn-down teeth, intended for adults with good oral health.
The subject device is identical to the predicate in chemical formulation, materials, mechanism of action, mode of application, manufacturing process, and packaging configuration. The only modification is expansion of intended users from dental professionals to laypersons.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov