FDA 510(k) Application Details - K211489

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K211489
Device Name	Material, Impression
Applicant	Nanchang Dental Bright Technology Co., Ltd Building 182, Jiahai Industrial Park, No. 2799, Tianxiang Avenue, High-Tech Zone Nanchang CN Other 510(k) Applications for this Company
Contact	Justin Qin 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	05/13/2021
Decision Date	07/28/2021
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