FDA 510(k) Application Details - K250710

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K250710
Device Name	Resin, Root Canal Filling
Applicant	Enpuno Co., Ltd No. 201, Haiping Park Production Plant3, No.229, Guyuan Road Changsha High-tech Development Zone Changsha City 410205 CN Other 510(k) Applications for this Company
Contact	Chengfa Huang 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	03/10/2025
Decision Date	06/11/2025
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