FDA 510(k) Application Details - K132145

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K132145
Device Name	Aligner, Sequential
Applicant	DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 YORK, PA 17404 US Other 510(k) Applications for this Company
Contact	HELEN LEWIS 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	07/11/2013
Decision Date	10/11/2013
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