UltraEZ— 510(k) K261404
Substantially EquivalentUltradent Products, Inc.
FDA 510(k) clearance K261404 for UltraEZ, Substantially Equivalent on 2026-04-30. Applicant: Ultradent Products, Inc.. Device class: 2.
Summary
Ultradent Products' UltraEZ is filed under product code LBH (Varnish, Cavity). The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 872.3260. Dental is both the classification panel and the review panel, and it came in as a Special 510(k).
Ultradent filed from South Jordan, Utah. The decision came 1 calendar day after FDA received it (April 29 to April 30, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Ultradent Products, Inc.
- Product code
- Product code LBH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3260
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Jordan, UT, US
Recent devices under product code LBH
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