Cleared Abbreviated

iCEM Universal Plus

K254063 · Kulzer, LLC · Dental
Dec 2025
Decision
2d
Days
Class 2
Risk

About This 510(k) Submission

K254063 is an FDA 510(k) clearance for the iCEM Universal Plus, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on December 19, 2025, 2 days after receiving the submission on December 17, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K254063 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2025
Decision Date December 19, 2025
Days to Decision 2 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275