K241114
- 510(k) number
- K241114
- Device name
- EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)
- Applicant
- Ewoosoft Co., Ltd. KR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-07-23
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K241114.pdf
Official FDA record: K241114
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.