K250953
- 510(k) number
- K250953
- Device name
- EQUIA LC ONE
- Applicant
- GC America, Inc. IL · US
- Product code
- EMA — Cement, Dental
- Decision date
- 2025-09-19
- Date received
- 2025-03-28
- 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: K250953.pdf
Official FDA record: K250953
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.