FUORECAM

Laser, Fluorescence Caries Detection

THERAPEUTIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Therapeutic Technologies, Inc. with the FDA for Fuorecam.

Pre-market Notification Details

Device IDK093705
510k NumberK093705
Device Name:FUORECAM
ClassificationLaser, Fluorescence Caries Detection
Applicant THERAPEUTIC TECHNOLOGIES, INC. 351 W.10TH ST., STE. 222 Indianapolis,  IN  46202 -4119
ContactBart Collins
CorrespondentBart Collins
THERAPEUTIC TECHNOLOGIES, INC. 351 W.10TH ST., STE. 222 Indianapolis,  IN  46202 -4119
Product CodeNBL  
CFR Regulation Number872.1745 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-01
Decision Date2010-04-23
Summary:summary

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