FDA 510(k) Application Details - K160850

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K160850
Device Name	Implant, Endosseous, Root-Form
Applicant	SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI 10018 SOK. NO 7 ITOB ORGANIZE SANAYI BOLGESI TEKELI TR-35477 TR Other 510(k) Applications for this Company
Contact	EZGI ERDEM 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	03/28/2016
Decision Date	08/04/2017
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