FDA 510(k) Application Details - K081961

Device Classification Name	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations   More FDA Info for this Device
510(K) Number	K081961
Device Name	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Applicant	BRONTES TECHNOLOGIES 20310 SW 48TH ST. SOUTHWEST RANCHES, FL 33332 US Other 510(k) Applications for this Company
Contact	JOHN GREENBAUM Other 510(k) Applications for this Contact
Regulation Number	872.3661   More FDA Info for this Regulation Number
Classification Product Code	NOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2008
Decision Date	09/05/2008
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