FDA 510(k) Application Details - K063495

Device Classification Name	Implant, Endosseous, Orthodontic   More FDA Info for this Device
510(K) Number	K063495
Device Name	Implant, Endosseous, Orthodontic
Applicant	BIOMATERIALS KOREA INC. 13 RED FOX LANE LITTLETON, CO 80127 US Other 510(k) Applications for this Company
Contact	KEVIN WALLS, RAC Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	OAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2006
Decision Date	07/26/2007
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