iCEM Universal Plus— 510(k) K254063

Substantially Equivalent

Kulzer, LLC

FDA 510(k) clearance K254063 for iCEM Universal Plus, Substantially Equivalent on 2025-12-19. Applicant: Kulzer, LLC. Device class: 2.

Clearance details

Applicant: Kulzer, LLC
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2025-12-17
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

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K261937 — PacTemp Automix NE2026-08-07
K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

More clearances from Kulzer, LLC

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K243910 — Retraxil2025-09-24
K240660 — Signum composite flow +6 more2024-09-17
K233868 — dima Print Teeth & Temp2024-05-23
K230644 — Signum opaque F2023-09-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.