FDA 510(k) Application Details - K083543

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K083543
Device Name	Implant, Endosseous, Root-Form
Applicant	DENOVIS MEDICAL, LLC 11234 EL CAMINO REAL SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	KEVIN A THOMAS 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	11/28/2008
Decision Date	03/06/2009
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