DIAGNOdent 2095 2095

GUDID EKAV057405000

This is a medical device.

Kaltenbach & Voigt GmbH

Dental caries detector, optical induced fluorescence

• Primary Device ID: EKAV057405000
• NIH Device Record Key: a3ebd105-8707-4fa7-990c-f0b666c44d80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIAGNOdent 2095
• Version Model Number: 0.574.0500
• Catalog Number: 2095
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 80 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV057405000 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-26

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