K254063
- 510(k) number
- K254063
- Device name
- iCEM Universal Plus
- Applicant
- Kulzer, LLC IN · US
- Product code
- EMA — Cement, Dental
- Decision date
- 2025-12-19
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K254063.pdf
Official FDA record: K254063
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.