FDA UDI
In Commercial Distribution
🇺🇸 United States
EzDent Web
DI: 08800019700395
·
Model: v1.2
·
EWOO SOFT Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EzDent Web
- Primary DI
- 08800019700395
- Version / Model
- v1.2
- Company Name
- EWOO SOFT Co., Ltd
- Labeler DUNS
- 688379797
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-14
- Public Version
- 1
- Public Version Date
- 2023-07-24
- Public Version Status
- New
- Public Device Record Key
- af2cc73c-c4b3-4c64-955e-b3694c43d852
Device Description
EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equipped with management and processing system for various 2D and 3D images. In addition, EzDent Web provides media contents for patient consultation and user friendly instruction to assist your use of the software. EzDent Web provides you with the following functions using patient images in 2D and 3D. - Manage patient information - View patient images in 2D/3D using tools for image processing and view function. - Use high resolution 3D VR to view 3D images in the optimized view for user intent. - Consult patients using media contents provided for patient consultation.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40876 | General-purpose dental x-ray system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800019700395 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230468 | 000 |