EzDent-i/ E2/ Prora View/ Smart M Viewer— 510(k) K211795

Substantially Equivalent

Ewoosoft Co., Ltd.

FDA 510(k) clearance K211795 for EzDent-i/ E2/ Prora View/ Smart M Viewer, Substantially Equivalent on 2021-10-04. Applicant: Ewoosoft Co., Ltd..

Clearance details

Applicant: Ewoosoft Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-06-10
Decision date: 2021-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.