FDA 510(k) Application Details - K242934

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K242934
Device Name	Resin, Root Canal Filling
Applicant	Longly Biotechnology (Wuhan) Co., Ltd. No.02 of 2nd Floor, Building A2-2, Optics Valley Biomedical Park, Gaoxin Avenue No.858, East Lake High-tech Development Wuhan 430000 CN Other 510(k) Applications for this Company
Contact	Liang Yan Other 510(k) Applications for this Contact
Regulation Number	872.3820   More FDA Info for this Regulation Number
Classification Product Code	KIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2024
Decision Date	12/12/2024
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