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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 DRIVE
DURHAM,  NC  27703
Applicant Contact CHARLES H KYPER
Correspondent
NEKS TECHNOLOGIES, INC.
208 BARRINGTON OVERLOOK DRIVE
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
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