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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 K093705
Device Name FUORECAM
Applicant
Therapeutic Technologies, Inc.
351 W.10th St., Suite 222
Indianapolis,  IN  46202 -4119
Applicant Contact BART COLLINS
Correspondent
Therapeutic Technologies, Inc.
351 W.10th St., Suite 222
Indianapolis,  IN  46202 -4119
Correspondent Contact BART COLLINS
Regulation Number872.1745
Classification Product Code
NBL  
Date Received12/01/2009
Decision Date 04/23/2010
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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