FDA 510(k) Application Details - K231259

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K231259
Device Name	Resin, Root Canal Filling
Applicant	Innovative BioCeramix, Inc. 8218 North Fraser Way RM 101 Burnaby V3N0E9 CA Other 510(k) Applications for this Company
Contact	Quanzu Yang 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	05/01/2023
Decision Date	05/31/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review