FDA 510(k) Application Details - K233954

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K233954
Device Name	Material, Impression
Applicant	B&E Korea Co., Ltd. 995-16, Baran-ro, Jeongnam-myeon Hwaseong-si 18515 KR Other 510(k) Applications for this Company
Contact	Jayong Shin 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	12/15/2023
Decision Date	02/13/2024
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