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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Transmission Caries Detector
510(k) Number K060080
Device Name DIAGNODENT 2190 WITH PERIODONTAL PROBE
Applicant
Kavo Dental Corporation
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Kavo Dental Corporation
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number872.1745
Classification Product Code
NTK  
Date Received01/10/2006
Decision Date 02/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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