FDA 510(k) Application Details - K193113

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K193113
Device Name	Crown And Bridge, Temporary, Resin
Applicant	GC America Inc. 3737 W. 127th Street Alsip, IL 60803 US Other 510(k) Applications for this Company
Contact	Mark Heiss Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2019
Decision Date	07/09/2020
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