FDA 510(k) Application Details - K052968

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K052968
Device Name	Implant, Endosseous, Root-Form
Applicant	ORTHOLUTION CO., LTD. 5536 TROWBRIDGE DRIVE ATLANTA, GA 30338 US Other 510(k) Applications for this Company
Contact	CATHRYN CAMBRIA 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	10/21/2005
Decision Date	09/08/2006
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