FDA 510(k) Application Details - K191385

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K191385
Device Name	Material, Tooth Shade, Resin
Applicant	Coltene/Whaledent AG Feldwiesenstrasse 20 Altstatten 9450 CH Other 510(k) Applications for this Company
Contact	Wolfgang Dorner Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2019
Decision Date	10/29/2019
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