eco-x series

GUDID 08800005200199

'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, and oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions. In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.

HDX WILL CORP.

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• Primary Device ID: 08800005200199
• NIH Device Record Key: 299c6278-524f-4a47-8078-ce6926bcae93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eco-x series
• Version Model Number: eco-x
• Company DUNS: 689605054
• Company Name: HDX WILL CORP.
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr
• Phone: +82215882754
• Email: global@hdx.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800005200199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211159

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

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: 2022-03-01
• Device Publish Date: 2022-02-21

On-Brand Devices [eco-x series]

• 08800005200205: 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalo
• 08800005200199: 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalo