ScanX Swift 2.0 G8800, G8800A

GUDID E247G8800

Dental Image Plate Scanner

DÜRR DENTAL SE

Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner

• Primary Device ID: E247G8800
• NIH Device Record Key: 60a74d7c-2f1f-42b7-819a-1191c7a48f28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanX Swift 2.0
• Version Model Number: XPS07.1A1
• Catalog Number: G8800, G8800A
• 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: true
• 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	E247G8800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230095

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-07
• Device Publish Date: 2023-02-27

Devices Manufactured by DÜRR DENTAL SE

• E24721301004130 - VistaPosition Anterior: 2024-05-27
• E24721301004140 - VistaPosition Posterior: 2024-05-27
• E24721301004150 - VistaPosition Endo: 2024-05-27
• E24721301004160 - VistaPosition Bitewing: 2024-05-27
• E247G37101 - VistaPosition Anterior/ Posterior Kit Titanium: 2024-05-27
• E247G38101 - VistaPosition Anterior/ Posterior Kit: 2024-05-27
• E247732480 - ScanX Barrier Envelope, 100 Pcs, Size 0: 2023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
• E247732482 - ScanX Barrier Envelope, 300 Pcs, Size 2: 2023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).