DEXIS CariVu NA

GUDID EKAV101055700

This is a medical device.

Kaltenbach & Voigt GmbH

Dental caries detector, optical induced fluorescence

• Primary Device ID: EKAV101055700
• NIH Device Record Key: 4e6c7f1c-69e5-49fa-81a4-4f52b32a8f16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS CariVu
• Version Model Number: 1.010.5570
• 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: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -50 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101055700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123402

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

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