FDA 510(k) Application Details - K193484

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K193484
Device Name	Cement, Dental
Applicant	GC America Inc. 3737 W. 127th Street Alsip, IL 607803 US Other 510(k) Applications for this Company
Contact	Mark Heiss Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2019
Decision Date	07/02/2020
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