FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
EzDent Web
K Number: K211700
·
Decision Sep 28, 2021
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
31
Review Days
117
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EzDent Web
- K Number
- K211700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ewoosoft Co., Ltd.
- Date Received
- June 3, 2021
- Decision Date
- September 28, 2021
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
2D Hip Planning Software
FDA 510(k)
FDA Class 2
·Radiology
CustoMED Viewer
FDA 510(k)
FDA Class 2
·Radiology
Helion Viewer Suite
FDA 510(k)
FDA Class 2
·Radiology
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
FDA 510(k)
FDA Class 2
·Radiology
SubtleHD-PET (1.x)
FDA 510(k)
FDA Class 2
·Radiology
HipGuide (V 1.0.0.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Ewoosoft Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250005 | Clever One | May 23, 2025 | Substantially Equivalent |
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Jul 23, 2024 | Substantially Equivalent |
| K231757 | Ez3D-i /E3 | Jul 14, 2023 | Substantially Equivalent |
| K230468 | EzDent Web | Apr 21, 2023 | Substantially Equivalent |
| K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Feb 17, 2023 | Substantially Equivalent |
| K222069 | Ez3D-i/E3 | Sep 6, 2022 | Substantially Equivalent |
| K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | Aug 12, 2022 | Substantially Equivalent |
| K220003 | EzOrtho v1.3 | Feb 23, 2022 | Substantially Equivalent |
| K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Oct 4, 2021 | Substantially Equivalent |
| K211793 | EzOrtho | Aug 23, 2021 | Substantially Equivalent |