ProVecta 3D Prime

GUDID E2472210200389

DÜRR DENTAL SE

Cone beam computed tomography system, head/neck

• Primary Device ID: E2472210200389
• NIH Device Record Key: 7778b446-43b9-4d0a-919c-bb84565ea632
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProVecta 3D Prime
• Version Model Number: 2210200389
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E2472210200389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181432

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

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: 2019-02-15
• Device Publish Date: 2019-01-15

On-Brand Devices [ProVecta 3D Prime]

• E2472210200389: 2210200389
• E247A77610: X-Ray System
• E247A77500: X-Ray System