STAR-X

GUDID 08800005200151

Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

HDX WILL CORP.

Stationary intraoral dental x-ray system, digital

• Primary Device ID: 08800005200151
• NIH Device Record Key: 7f48f674-ea65-40b0-8cd7-1e493d3d3dfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAR-X
• Version Model Number: STAR-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: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@hdx.co.kr
• Phone: +82220035778
• Email: jason@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	08800005200151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190357

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2021-05-06
• Device Publish Date: 2021-04-28

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