FDA 510(k) Application Details - K191843

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K191843
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Amann Girrbach AG Herrschaftswiesen 1 Koblach 6842 AT Other 510(k) Applications for this Company
Contact	Debora Engel 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	07/09/2019
Decision Date	10/04/2019
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