DIAGNOdent pen 2190 2190

GUDID EKAV100270000

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

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 Issuing Agency	Device ID
HIBCC	EKAV100270000 [Primary]

NTK	Caries detector, laser light, transmission

Steralize Prior To Use	false
Device Is Sterile	false

EKAV101112130 - DIAGNOcam Vision Full HD	2024-02-09
EKAV101315000 - DIAGNOcam Vision Full HD	2024-02-09
EKAV101402800 - MASTERmatic LUX M45 L	2024-02-09
EKAV101002870 - Refill PROPHYflex perio tip	2023-04-25 PROPHYflex perio tip: Attachment for a focused beam for focused and gentle subgingival treatments as well as cleaning bridges, i
EKAV101509600 - INTRA LUX KL 703 LED Planmeca	2023-04-24
EKAV100703380 - Prophylaxe Set 2008	2022-08-16 This is a medical device.
EKAV200009220 - PROPHYflex perio tip	2022-08-16 This is a medical Device.
EKAV100270000 - DIAGNOdent pen 2190	2022-04-25This is a medical device.
EKAV100270000 - DIAGNOdent pen 2190	2022-04-25 This is a medical device.