ScanX Swift 2.0 G8800, G8800A

GUDID E247G8800

Dental Image Plate Scanner

DÜRR DENTAL SE

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).