FDA 510(k) Application Details - K201795

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K201795
Device Name	Material, Tooth Shade, Resin
Applicant	Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Karen Kakunes 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	06/30/2020
Decision Date	09/28/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review