FDA 510(k) Application Details - K201707

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K201707
Device Name	Material, Tooth Shade, Resin
Applicant	Dentscare LTDA Av. Edgar Nelson Meister, 474 Joinville 89219-501 BR Other 510(k) Applications for this Company
Contact	Roberta Uyara 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	06/22/2020
Decision Date	12/22/2020
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