FDA 510(k) Application Details - K093705

Device Classification Name Laser,Fluorescence Caries Detection

  More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact BART COLLINS
Other 510(k) Applications for this Contact
Regulation Number 872.1745

  More FDA Info for this Regulation Number
Classification Product Code NBL
Other 510(k) Applications for this Device

  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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact