ProVecta 3D Prime Ceph

GUDID E247A78500

X-Ray System

DÜRR DENTAL SE

Cone beam computed tomography system, head/neck

• Primary Device ID: E247A78500
• NIH Device Record Key: 5ea376f2-8a1d-418f-865e-84e4333ab3cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProVecta 3D Prime Ceph
• Version Model Number: A7850
• 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	E247A78500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193139

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 Ceph]

• E2472210200729: 2210200729
• E247A78500: X-Ray System
• E247A78610: X-Ray System