DBSWIN 5.11.0

GUDID E247E72000

DÜRR DENTAL SE

General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software General-purpose dental x-ray system application software

• Primary Device ID: E247E72000
• NIH Device Record Key: 61dad85b-eb22-4206-a38a-becd0d71d9bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBSWIN 5.11.0
• Version Model Number: E7200
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E247E72000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161444

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-16
• Device Publish Date: 2016-09-21

Devices Manufactured by DÜRR DENTAL SE

• 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).
• E247G8800 - ScanX Swift 2.0: 2023-03-07 Dental Image Plate Scanner
• E247G8900 - ScanX Swift View 2.0: 2023-03-07 Dental Image Plate Scanner
• E247E7300A10 - VisionX: 2022-04-04 VisionX version 3.0.x
• E247A78610 - ProVecta 3D Prime Ceph: 2022-03-14 X-Ray System
• E247J21101 - CamX Elara: 2022-03-14
• E247J27111 - CamX Cam Interchangeable Head: 2022-03-14