FDA 510(k) Application Details - K201684

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K201684
Device Name	Material, Impression
Applicant	Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District Rizhao City 276800 CN Other 510(k) Applications for this Company
Contact	Maggie Zheng Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2020
Decision Date	09/24/2020
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