FDA 510(k) Application Details - K192108

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K192108
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Panthera Dental Inc. 2035 rue du Haut-Bord Quebec city G1n 4N7 CA Other 510(k) Applications for this Company
Contact	Martine Fortin Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2019
Decision Date	04/08/2020
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