DIAGNOdent pen 2190 2190

GUDID EKAV100270000

This is a medical device.

KaVo Dental GmbH

Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence Dental caries detector, optical induced fluorescence

• Primary Device ID: EKAV100270000
• NIH Device Record Key: 40ac3ff6-1796-424b-9fb4-5cbbac5aa1b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIAGNOdent pen 2190
• Version Model Number: 1.002.7000
• Catalog Number: 2190
• Company DUNS: 333710619
• Company Name: KaVo Dental 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: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.com
• Phone: +18885286872
• Email: techservice@kavo.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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV100270000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060080

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: 2022-04-25
• Device Publish Date: 2022-04-15

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