WillCeph

GUDID 08800005200168

WillCeph is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images, including digitla photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions

HDX WILL CORP.

General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software

• Primary Device ID: 08800005200168
• NIH Device Record Key: 5079ca8e-eeb9-45b9-b0da-90893f8df0e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WillCeph
• Version Model Number: WillCeph
• 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: false
• 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	08800005200168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172168

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-01-06
• Device Publish Date: 2018-05-03

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• 08800005200205 - eco-x series: 2022-03-01 'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by
• 08800005200380 - DENTRIα series: 2022-02-17 The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthod
• 08800005200397 - DENTRIα series: 2022-02-17 The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthod
• 08800005200403 - DENTRIα series: 2022-02-17 The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthod