EzDent Web— 510(k) K230468

Name: FDA 510(k) clearance K230468
Creator: U.S. Food and Drug Administration
Published: 2023-04-21

Substantially Equivalent

Ewoosoft Co., Ltd.

FDA 510(k) clearance K230468 for EzDent Web, Substantially Equivalent on 2023-04-21. Applicant: Ewoosoft Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ewoosoft Co., Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-02-21
Decision date: 2023-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Ewoosoft Co., Ltd.

view all

K250005 — Clever One2025-05-23
K241114 — EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)2024-07-23
K231757 — Ez3D-i /E32023-07-14
K223820 — EzDent-i / E2 / Prora View/ Smart M Viewer2023-02-17
K222069 — Ez3D-i/E32022-09-06

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.