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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 K111321
Device Name REMOTE VIEW SOFTWARE
Applicant
Cariescan , Ltd.
Unit 5 Gateway W.,
Luna Place, Technology Park
Dundee, Angus,  GB DD2 1XZ
Applicant Contact NIKOLA SKELLY
Correspondent
Cariescan , Ltd.
Unit 5 Gateway W.,
Luna Place, Technology Park
Dundee, Angus,  GB DD2 1XZ
Correspondent Contact NIKOLA SKELLY
Regulation Number872.1745
Classification Product Code
NBL  
Date Received05/11/2011
Decision Date 05/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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