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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name caries detector, laser light, transmission
510(k) Number K062961
Device Name MICROLUX TRANSILLUMINATOR
Applicant
ADDENT, INC.
43 MIRY BROOK RD.
DANBURY,  CT  06810
Applicant Contact JOSHUA FRIEDMAN
Correspondent
ADDENT, INC.
43 MIRY BROOK RD.
DANBURY,  CT  06810
Correspondent Contact JOSHUA FRIEDMAN
Regulation Number872.1745
Classification Product Code
NTK  
Date Received09/29/2006
Decision Date 02/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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