FDA 510(k) Application Details - K201307

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K201307
Device Name	Material, Tooth Shade, Resin
Applicant	VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven 27472 DE Other 510(k) Applications for this Company
Contact	M. Th. Plaumann 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	05/15/2020
Decision Date	07/08/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review