K250566
- 510(k) number
- K250566
- Device name
- EsCem RMGI
- Applicant
- Spident Co., Ltd. KR
- Product code
- EMA — Cement, Dental
- Decision date
- 2025-06-20
- Date received
- 2025-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250566.pdf
Official FDA record: K250566
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.