DEXIS CariVu 3-in-1 by KaVo U NA

GUDID EKAV101317000

The DEXIS CariVu 3-in-1 by KaVo is indicated as an aid for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.

Kaltenbach & Voigt GmbH

Dental caries detector, optical induced fluorescence

• Primary Device ID: EKAV101317000
• NIH Device Record Key: b4725b4d-9d83-4ae1-b057-a36a6a6d3d14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS CariVu 3-in-1 by KaVo U
• Version Model Number: 1.013.1700
• Catalog Number: NA
• Company DUNS: 332864359
• Company Name: Kaltenbach & Voigt GmbH
• 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

Customer Support Contacts

• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com
• Phone: +18882755286
• Email: techservice@kavokerr.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101317000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182712

FDA Product Code

• NTK: Caries detector, laser light, transmission

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: 2020-04-08
• Device Publish Date: 2020-03-31

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