FDA 510(k) Application Details - K121396

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K121396
Device Name	Aligner, Sequential
Applicant	DYNA FLEX 10403 International Plaza Dr. Northwest Plaza, MO 63074 US Other 510(k) Applications for this Company
Contact	MATTHEW MALABEY Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2012
Decision Date	08/14/2012
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