FDA 510(k) Application Details - K090234

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K090234
Device Name	Implant, Endosseous, Root-Form
Applicant	IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. CALABASAS HILLS, CA 91301 US Other 510(k) Applications for this Company
Contact	THOMAS GOTTENBOS 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	01/30/2009
Decision Date	05/15/2009
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