FDA 510(k) Application Details - K181157

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K181157
Device Name	Implant, Endosseous, Root-Form
Applicant	OsseoFuse International, Inc. 5023 North Parkway Calabasas Calabasas, CA 91302 US Other 510(k) Applications for this Company
Contact	Jennifer Cha 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	05/01/2018
Decision Date	05/24/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review