FDA 510(k) Application Details - K162482

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K162482
Device Name	Implant, Endosseous, Root-Form
Applicant	A. B. Dental Device Ltd. 19 Hayalomim St. Ashdod 77101 IL Other 510(k) Applications for this Company
Contact	Gabi Krauss 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	09/06/2016
Decision Date	09/15/2017
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