ScanX Intraoral View

GUDID E247G86000

DÜRR DENTAL SE

Radiography digital imaging scanner

• Primary Device ID: E247G86000
• NIH Device Record Key: b3fd5954-27fe-437e-82d0-a5447c25630c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanX Intraoral View
• Version Model Number: G8600
• Company DUNS: 315563684
• Company Name: DÜRR DENTAL SE
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E247G86000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170733

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: 2
• Public Version Date: 2018-08-23
• Device Publish Date: 2018-07-06

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• E24721301004140 - VistaPosition Posterior: 2024-05-27
• E24721301004150 - VistaPosition Endo: 2024-05-27