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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name diagnostic light, soft tissue detector
510(k) Number K121282
Models 110035, 110053, 110090
Device Name MICROLUX/DL MICROLUX/BLU BIO/SCREEN
Original Applicant
ADDENT, INC.
43 miry brook rd.
danbury,  CT  06810
Original Contact joshua friedman
Regulation Number872.6350
Classification Product Code
NXV  
Date Received04/30/2012
Decision Date 07/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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