Ez3D-i

GUDID 08800019700234

Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

EWOO SOFT Co., Ltd

General-purpose dental x-ray system application software

• Primary Device ID: 08800019700234
• NIH Device Record Key: edfda120-2004-4521-9d01-2e30e5d85188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ez3D-i
• Version Model Number: v5.3
• 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	08800019700234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211791

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: 2021-11-16
• Device Publish Date: 2021-11-08

On-Brand Devices [Ez3D-i]

• 08800019700173: Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial
• 08800019700234: Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial
• 08800019700340: Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial
• 08800019700401: Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial