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FDA 510(k)

UltraEZ

K-Number: K261404 · 2026-04-30

ApplicantUltradent Products, Inc.
Decision Date2026-04-30
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UltraEZ is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2026-04-30 under 510(k) 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. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K261404.

When did UltraEZ receive FDA 510(k) clearance?

UltraEZ received FDA 510(k) clearance on 2026-04-30, under 510(k) number K261404.

Who is the listed applicant for UltraEZ?

The FDA 510(k) record lists Ultradent Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraEZ?

The FDA product code for UltraEZ is LBH.

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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.

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