DBSWIN

GUDID E247E7200A0

Dental Imaging Software. Software Version 5.x.x.

DÜRR DENTAL SE

General-purpose dental x-ray system application software

• Primary Device ID: E247E7200A0
• NIH Device Record Key: ebc3a1c6-e458-41e9-974d-31ce6421615d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBSWIN
• Version Model Number: E7200A
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E247E7200A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190629

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: 2019-04-17
• Device Publish Date: 2019-04-09

Devices Manufactured by DÜRR DENTAL SE

• E24721301003290 - VistaPosition Anterior: 2026-03-23 Dental x-ray film holder.
• E24721301003300 - VistaPosition Posterior: 2026-03-23 Dental x-ray film holder.
• E24721301003320 - VistaPosition Endo: 2026-03-23 Dental x-ray film holder.
• E24721301003330 - VistaPosition Bitewing: 2026-03-23 Dental x-ray film holder.
• E2472110100003A20 - VistaSoft: 2025-09-30 Dental Imaging Software.
• E24721301004130 - VistaPosition Anterior: 2024-05-27
• E24721301004140 - VistaPosition Posterior: 2024-05-27
• E24721301004150 - VistaPosition Endo: 2024-05-27