FDA 510(k) Application Details - K052419

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K052419
Device Name	Implant, Endosseous, Root-Form
Applicant	BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH BIRMINGHAM, AL 35243 US Other 510(k) Applications for this Company
Contact	WINSTON GREER 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	09/02/2005
Decision Date	09/20/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review