AIOBIO

GUDID 08800043200090

AIOBIO CO.,LTD

Intraoral optical scanning system

• Primary Device ID: 08800043200090
• NIH Device Record Key: 680b802e-21d4-4375-a566-a04f436f1b64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIOBIO
• Version Model Number: LINKDENS QC
• Company DUNS: 694894136
• Company Name: AIOBIO CO.,LTD
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800043200090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221275

FDA Product Code

• NBL: Laser, Fluorescence Caries Detection

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: 2024-12-10
• Device Publish Date: 2024-12-02

On-Brand Devices [AIOBIO]

• 08800043200199: W-Block
• 08800043200069: W-Block
• 08800043200038: Qraypen
• 08800043200212: LINKDENS VU
• 08800043200090: LINKDENS QC
• 08800043200052: Qscan Plus