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FDA 510(k)

iCEM Universal Plus

K-Number: K254063 · 2025-12-19

ApplicantKulzer, LLC
Decision Date2025-12-19
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

iCEM Universal Plus is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K254063. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iCEM Universal Plus?

iCEM Universal Plus is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Kulzer, LLC. The 510(k) number is K254063.

When did iCEM Universal Plus receive FDA 510(k) clearance?

iCEM Universal Plus received FDA 510(k) clearance on 2025-12-19, under 510(k) number K254063.

Who is the listed applicant for iCEM Universal Plus?

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

What is the FDA product code for iCEM Universal Plus?

The FDA product code for iCEM Universal Plus is EMA.

Other records listing Kulzer, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneK243910RetraxilK240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-activeK233868dima Print Teeth & TempK230644Signum opaque FK220605Venus Bulk Flow ONE

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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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