KaVo OP 3D Vision

GUDID EKAV083082000

V10

Imaging Sciences International

Cone beam computed tomography system, head/neck

• Primary Device ID: EKAV083082000
• NIH Device Record Key: 8589a4ca-d3e2-473e-b76b-6091eabbe241
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KaVo OP 3D Vision
• Version Model Number: 0.830.8200
• Company DUNS: 800111106
• Company Name: Imaging Sciences International
• 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: false
• 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	EKAV083082000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162085

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: 2022-01-31
• Device Publish Date: 2022-01-21

On-Brand Devices [KaVo OP 3D Vision]

• EKAV083083000: V17
• EKAV083082000: V10
• EKAV083081000: V8