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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., STE. 222
INDIANAPOLIS,  IN  46202 -4119
Applicant Contact BART COLLINS
Correspondent
THERAPEUTIC TECHNOLOGIES, INC.
351 W.10TH ST., STE. 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
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