FDA 510(k) Application Details - K190217

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K190217
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Aidite (Qinhuangdao) Technology Co., Ltd. No.9 Dushan Road,Economic and Technological Development Zone Qinhuangdao 066000 CN Other 510(k) Applications for this Company
Contact	Zhang Wei Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2019
Decision Date	12/17/2020
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