FDA 510(k) Application Details - K170207

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K170207
Device Name	Resin, Root Canal Filling
Applicant	Itena Clinical 83 Avenue Foch Paris 75116 FR Other 510(k) Applications for this Company
Contact	Charles Peyre 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	01/24/2017
Decision Date	07/31/2017
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