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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 WEST,
LUNA PLACE, TECHNOLOGY PARK
DUNDEE, ANGUS,  GB DD2 1XZ
Applicant Contact NIKOLA SKELLY
Correspondent
CARIESCAN LTD.
UNIT 5 GATEWAY WEST,
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
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