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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 K090598
Device Name CARIESCAN PRO
Applicant
CARIESCAN LTD.
PROSPECT BUSINESS CENTRE
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Applicant Contact NIKOLA SKELLY
Correspondent
CARIESCAN LTD.
PROSPECT BUSINESS CENTRE
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Correspondent Contact NIKOLA SKELLY
Regulation Number872.1745
Classification Product Code
NBL  
Date Received03/05/2009
Decision Date 12/15/2009
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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