SensorX Size #1

GUDID E247G9510A1

Extraoral source x-ray system

DÜRR DENTAL SE

Dental digital imaging sensor, intraoral

• Primary Device ID: E247G9510A1
• NIH Device Record Key: 4932709d-7a86-4729-8e9f-cb6071f4f1a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SensorX Size #1
• Version Model Number: G9510A
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E247G9510A1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203116

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: 2021-04-09
• Device Publish Date: 2021-04-01

On-Brand Devices [SensorX Size #1]

• E247G9510A1: Extraoral source x-ray system
• E247G95101: Extraoral source x-ray system