FDA 510(k) Application Details - K240446

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K240446
Device Name	Resin, Root Canal Filling
Applicant	Shiva Products 214 Bluebell Indl. Estate Chinchpada, Vasai East, Dist Palghar 401208 IN Other 510(k) Applications for this Company
Contact	Urvi Doshi 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	02/15/2024
Decision Date	07/30/2024
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