FDA 510(k) Application Details - K081393

Device Classification Name	Implant, Endosseous, Orthodontic   More FDA Info for this Device
510(K) Number	K081393
Device Name	Implant, Endosseous, Orthodontic
Applicant	G & H WIRE CO. 11460 NORTH MERIDIAN STREET SUITE 150 CARMEL, IN 46032 US Other 510(k) Applications for this Company
Contact	CARRI GRAHAM 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	05/19/2008
Decision Date	08/21/2008
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