FDA 510(k) Application Details - K181580

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K181580
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Cortex Dental Implants Industries Ltd. Shlomi Industrial Estate Shlomi 22832 IL Other 510(k) Applications for this Company
Contact	Ronit Polack 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	06/15/2018
Decision Date	01/29/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review