EzDent-i/ E2/ Prora View/ Smart M Viewer— 510(k) K202116

Substantially Equivalent

Ewoosoft Co., Ltd.

FDA 510(k) clearance K202116 for EzDent-i/ E2/ Prora View/ Smart M Viewer, Substantially Equivalent on 2020-08-21. Applicant: Ewoosoft Co., Ltd..

Clearance details

Applicant: Ewoosoft Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-07-30
Decision date: 2020-08-21
Decision: Substantially Equivalent
Clearance type: Special
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.