FDA 510(k) Application Details - K182118

Device Classification Name	Dam, Rubber   More FDA Info for this Device
510(K) Number	K182118
Device Name	Dam, Rubber
Applicant	Mavrik Dental Systems Ltd 25 Ha Haroshet Street, 6th floor Raanana IL Other 510(k) Applications for this Company
Contact	Sherwyn Davidson Other 510(k) Applications for this Contact
Regulation Number	872.6300   More FDA Info for this Regulation Number
Classification Product Code	EIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2018
Decision Date	05/03/2019
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