K254063 is an FDA 510(k) clearance for the iCEM Universal Plus. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K254063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |