FDA 510(k) Application Details - K122065

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	K122065
Device Name	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Applicant	ORMCO CORP. 1717 WEST COLLINS AVENUE ORANGE, CA 92867 US Other 510(k) Applications for this Company
Contact	Wendy Garman 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	07/13/2012
Decision Date	02/08/2013
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