UltraEZ
K-Number: K261404 · 2026-04-30
ApplicantUltradent Products, Inc.
Decision Date2026-04-30
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
UltraEZ is a medical device manufactured by Ultradent Products, Inc.. It received FDA 510(k) clearance on 2026-04-30 under approval number K261404. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UltraEZ?
UltraEZ is a medical device that received FDA 510(k) clearance on 2026-04-30. It is manufactured by Ultradent Products, Inc.. The 510(k) number is K261404.
When was UltraEZ approved by the FDA?
UltraEZ received FDA 510(k) clearance on 2026-04-30, under approval number K261404.
What company makes UltraEZ?
UltraEZ is manufactured by Ultradent Products, Inc..
What is the FDA product code for UltraEZ?
The FDA product code for UltraEZ is LBH.
Related Devices (Code: LBH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.