FDA 510(k) Application Details - K203309

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K203309
Device Name	Implant, Endosseous, Root-Form
Applicant	JJGC Ind·stria e ComΘrcio de Materiais Dentßrios SA Av. Juscelino Kubitschek de Oliveira, 3291 û CIC Curitiba 81270-200 BR Other 510(k) Applications for this Company
Contact	Mariana Soares Hartmann 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	11/10/2020
Decision Date	07/06/2021
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