FDA 510(k) Application Details - K214086

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K214086
Device Name	Material, Impression
Applicant	Genoss Co., Ltd. 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu Suwon-si 16229 KR Other 510(k) Applications for this Company
Contact	Woojung Park 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	12/27/2021
Decision Date	12/15/2022
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