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FDA 510(k) Application Details - K093705
Device Classification Name
Laser,Fluorescence Caries Detection
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510(K) Number
K093705
Device Name
Laser,Fluorescence Caries Detection
Applicant
THERAPEUTIC TECHNOLOGIES, INC.
351 W.10TH ST., STE. 222
INDIANAPOLIS, IN 46202-4119 US
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BART COLLINS
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Regulation Number
872.1745
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Classification Product Code
NBL
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More FDA Info for this Product Code
Date Received
12/01/2009
Decision Date
04/23/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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