EzOrtho

GUDID 08800019700159

EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.

EWOO SOFT Co., Ltd

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• Primary Device ID: 08800019700159
• NIH Device Record Key: 51794ec8-da09-435e-890e-717d64c75e47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EzOrtho
• Version Model Number: 1.0
• 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	08800019700159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192888

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: 2020-12-03
• Device Publish Date: 2020-11-25

On-Brand Devices [EzOrtho]

• 08800019700203: EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image
• 08800019700159: EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image
• 08800019700258: EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image
• 08800019700319: EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image