FDA 510(k) Application Details - K192839

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K192839
Device Name	Implant, Endosseous, Root-Form
Applicant	D.S.P Industrial Eireli Rua Marechal Floriano Peixoto 303 - Ouro Verde II Campo Largo 83606-290 BR Other 510(k) Applications for this Company
Contact	Celio Gilson Netzel 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	09/26/2019
Decision Date	02/11/2021
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