FDA 510(k) Application Details - K190537

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K190537
Device Name	Resin, Root Canal Filling
Applicant	Angelus Industria de Produtos Odontologicos S/A Rua Waldir Landgraf, 101 Londrina 86.031-218 BR Other 510(k) Applications for this Company
Contact	Paulo Sergio Calixto De Oliveira 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	03/04/2019
Decision Date	12/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review