EzDent-i / E2 / Prora View/ Smart M Viewer
FDA 510(k) K222145 · Ewoosoft Co., Ltd.
510(k) numberK222145
Submission
- Device name
- EzDent-i / E2 / Prora View/ Smart M Viewer
- Applicant
- Ewoosoft Co., Ltd.
Hwaseong-Si, KR - Received
- July 20, 2022
- Decision date
- August 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K250005 | Clever OneQIH · Traditional | 05/23/2025SE |
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)LLZ · Special | 07/23/2024SE |
| K231757 | Ez3D-i /E3QIH · Special | 07/14/2023SE |
| K230468 | EzDent WebLLZ · Traditional | 04/21/2023SE |
| K223820 | EzDent-i / E2 / Prora View/ Smart M ViewerLLZ · Traditional | 02/17/2023SE |
| K222069 | Ez3D-i/E3LLZ · Traditional | 09/06/2022SE |
| K220003 | EzOrtho v1.3LLZ · Traditional | 02/23/2022SE |
| K211795 | EzDent-i/ E2/ Prora View/ Smart M ViewerLLZ · Traditional | 10/04/2021SE |
| K211700 | EzDent WebLLZ · Traditional | 09/28/2021SE |
| K211793 | EzOrthoLLZ · Traditional | 08/23/2021SE |
Questions and answers
When was EzDent-i / E2 / Prora View/ Smart M Viewer cleared by the FDA?
EzDent-i / E2 / Prora View/ Smart M Viewer (K222145) received a 510(k) decision of Substantially Equivalent on August 12, 2022, 23 days after the submission was received.
What is the product code of K222145?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.