ProVecta 3D Prime

GUDID E247A77610

X-Ray System

DÜRR DENTAL SE

Cone beam computed tomography system, head/neck

• Primary Device ID: E247A77610
• NIH Device Record Key: 42c4a87a-81d8-4298-8401-3c93a78f14e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProVecta 3D Prime
• Version Model Number: A7761
• 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	E247A77610 [Primary]

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: 2021-02-10
• Device Publish Date: 2021-02-02

On-Brand Devices [ProVecta 3D Prime]

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