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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Fluorescence Caries Detection
510(k) Number K043156
Device Name D-CARIE, MODEL N121-M1
Applicant
Neks Technologies, Inc.
208 Barrington Overlook Dr.
Durham,  NC  27703
Applicant Contact CHARLES H KYPER
Correspondent
Neks Technologies, Inc.
208 Barrington Overlook Dr.
Durham,  NC  27703
Correspondent Contact CHARLES H KYPER
Regulation Number872.1745
Classification Product Code
NBL  
Date Received11/15/2004
Decision Date 04/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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