FDA 510(k) Application Details - K182228

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K182228
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park Bar Lev Industrial Park 2015600 IL Other 510(k) Applications for this Company
Contact	Arbel Shezaf 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	08/16/2018
Decision Date	01/28/2019
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