K242366
- 510(k) number
- K242366
- Device name
- OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
- Applicant
- Overfibers S.R.L. IT
- Product code
- EMA — Cement, Dental
- Decision date
- 2025-01-10
- Date received
- 2024-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242366.pdf
Official FDA record: K242366
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.