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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 K082668
Device Name 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 Received09/12/2008
Decision Date 01/23/2009
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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