FDA 510(k) Application Details - K180649

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K180649
Device Name	Material, Tooth Shade, Resin
Applicant	Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 US Other 510(k) Applications for this Company
Contact	Mauro Malzyner 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	03/13/2018
Decision Date	06/11/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review