K253337
- 510(k) number
- K253337
- Device name
- REGEN Bioactive Cement
- Applicant
- Inter-Med, Inc. WI · US
- Product code
- EMA — Cement, Dental
- Decision date
- 2026-04-15
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253337.pdf
Official FDA record: K253337
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.