FDA 510(k) Application Details - K210797

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K210797
Device Name	Barrier, Synthetic, Intraoral
Applicant	B&Medi Co., Ltd. 56-33, Chukhang-daero 296Beon-gil, Jung-gu Incheon 22339 KR Other 510(k) Applications for this Company
Contact	Taesu Kwon Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2021
Decision Date	08/18/2022
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