FDA 510(k) Application Details - K214071

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K214071
Device Name	Crown And Bridge, Temporary, Resin
Applicant	SPIDENT CO., LTD. 203 & 312, Korea Industrial Complex, 722 Gojan-Dong, Namdong-Gu 405-821 KR Other 510(k) Applications for this Company
Contact	J.M. Ahn 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	12/27/2021
Decision Date	03/10/2022
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