FDA 510(k) Application Details - K222144

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K222144
Device Name	Implant, Endosseous, Root-Form
Applicant	Biotem Co., Ltd. 57, Sasang-ro, 410 beon-gil, Sasang-gu Busan 46925 KR Other 510(k) Applications for this Company
Contact	Hong Koo Yeo Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2022
Decision Date	06/14/2023
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