DENTIOIII series

GUDID 08800005200113

The DENTIOIII is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic examinations. It is to be used only by dental practitioners and/or radiologists.

HDX WILL CORP.

Stationary panoramic dental x-ray system, digital

• Primary Device ID: 08800005200113
• NIH Device Record Key: 660c1596-0455-4a9a-ba78-8c7f1b850b20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTIOIII series
• Version Model Number: DENTIOIII
• 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	08800005200113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181297

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

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: 2019-03-04

On-Brand Devices [DENTIOIII series]

• 08800005200120: The DENTIOIII-S is intended for dental radiographic examination of the teeth and temporomandibul
• 08800005200113: The DENTIOIII is intended for dental radiographic examination of the teeth and temporomandibular