FDA 510(k) Application Details - K163194

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K163194
Device Name	Implant, Endosseous, Root-Form
Applicant	JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA AV. JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 - CIC CURITIBA 81270-200 BR Other 510(k) Applications for this Company
Contact	Julianne Lechechem Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2016
Decision Date	07/14/2017
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