FDA 510(k) Application Details - K153111

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K153111
Device Name	Implant, Endosseous, Root-Form
Applicant	Adin Dental Implants Systems Ltd. Alon Tavor Industrial Zone, P.O. Box 1128 Afula 1811101 IL Other 510(k) Applications for this Company
Contact	Ilana Lutvak Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2015
Decision Date	05/06/2016
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