FDA 510(k) Application Details - K161774

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K161774
Device Name	Material, Impression
Applicant	SPIDENT Co., Ltd. 203 & 312, Korea Indsutrial Complex, 722 Gojan-Dong, Namdong-Gu Incheon 21692 KR Other 510(k) Applications for this Company
Contact	J. M. Ahn 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	06/28/2016
Decision Date	09/30/2016
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