FDA 510(k) Application Details - K191034

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K191034
Device Name	Material, Impression
Applicant	Hygedent Inc. Room 210C, Building 4, No 5 Chaoqian Road, Science Industry Park, Changping Beijing 102299 CN Other 510(k) Applications for this Company
Contact	Peng Wang 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	04/18/2019
Decision Date	09/04/2019
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