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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
Device Name MICROLUX/DL MICROLUX/BLU BIO/SCREEN
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 Number872.6350
Classification Product Code
NXV  
Date Received04/30/2012
Decision Date 07/24/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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