DentalEye

GUDID 07350111570019

Dentaleye AB

Radiological PACS software

• Primary Device ID: 07350111570019
• NIH Device Record Key: 8ea4e50b-363b-4682-b5be-45bf86e37a1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentalEye
• Version Model Number: PRO
• Company DUNS: 633150982
• Company Name: Dentaleye AB
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350111570019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012439

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2024-02-13
• Device Publish Date: 2024-02-05

On-Brand Devices [DentalEye ]

• 07350111570026: Viewer
• 07350111570019: PRO