FDA 510(k) Application Details - K213643

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K213643
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Guangzhou Heygears Imc. Inc Block B2, 501, 601, Enterprise Accelerator, Kaifa District Guangzhou 510700 CN Other 510(k) Applications for this Company
Contact	Lin Liu 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	11/18/2021
Decision Date	01/14/2022
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