KaVo OP 3D Vision

GUDID D090083081000

V8

Dental Imaging Technologies Corporation

Cone beam computed tomography system, head/neck

• Primary Device ID: D090083081000
• NIH Device Record Key: addbceba-d118-4008-aa4b-f668fa3add53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KaVo OP 3D Vision
• Version Model Number: 0.830.8100
• Company DUNS: 800111106
• Company Name: Dental Imaging Technologies Corporation
• 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	D090083081000 [Primary]
HIBCC	EKAV083081000 [Previous]

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: 2022-03-14
• Device Publish Date: 2022-03-04

On-Brand Devices [KaVo OP 3D Vision]

• D090083083000: V17
• D090083082000: V10
• D090083081000: V8