DENTRIα series

GUDID 08800005200397

The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIα series used by physicians, dentists, and x-ray technologists.

HDX WILL CORP.

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• Primary Device ID: 08800005200397
• NIH Device Record Key: 9465ed9c-ef51-4831-ac46-7ff82eb594bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTRIα series
• Version Model Number: DENTRI-Cα
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800005200397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212254

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: 2022-02-17
• Device Publish Date: 2022-02-09

On-Brand Devices [DENTRIα series]

• 08800005200045: Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ray system, which
• 08800005200038: Device Description: DENTRIα Series is a dental CT, panoramic, cephalometric X-ray system, whic
• 08800005200021: Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, which is intended f
• 08800005200403: The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing gene
• 08800005200397: The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing gene
• 08800005200380: The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing gene