FDA 510(k) Application Details - K200676

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K200676
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Zirkonzahn srl Via An der Ahr 7 Gais 39030 IT Other 510(k) Applications for this Company
Contact	Julian Steger 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	03/16/2020
Decision Date	07/08/2020
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