EzDent Web

GUDID 08800019700395

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.

EWOO SOFT Co., Ltd

General-purpose dental x-ray system application software

• Primary Device ID: 08800019700395
• NIH Device Record Key: af2cc73c-c4b3-4c64-955e-b3694c43d852
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EzDent Web
• Version Model Number: v1.2
• Company DUNS: 688379797
• Company Name: EWOO SOFT Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019700395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230468

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [EzDent Web]

• 08800019700241: EzDent Web is a dental imaging software that enables you to save, manage, view and process patie
• 08800019700395: EzDent Web is a dental imaging software that enables you to save, manage, view and process patie