EzDent-i

GUDID 08800019700197

EzDent-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. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

EWOO SOFT Co., Ltd

General-purpose dental x-ray system application software

• Primary Device ID: 08800019700197
• NIH Device Record Key: a5ca8287-e155-4380-9045-0a50f84c9be5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EzDent-i
• Version Model Number: v3.1
• 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	08800019700197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202116

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: 2020-09-22
• Device Publish Date: 2020-09-14

On-Brand Devices [EzDent-i]

• 08800019700111: EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
• 08800019700197: EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
• 08800019700227: EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
• 08800019700357: EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
• 08800019700388: EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
• 08800019700531: EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci