FDA 510(k) Application Details - K131101

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K131101
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY 2560 ORCHARD PKWY SAN JOSE, CA 95131 US Other 510(k) Applications for this Company
Contact	MANAS M LELE Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2013
Decision Date	08/26/2013
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