FDA 510(k) Application Details - K080397

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K080397
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	AMERICAN DENTAL IMPLANT CORPORATION 2415 WILMINGTON RD. NEW CASTLE, PA 16105 US Other 510(k) Applications for this Company
Contact	GINA HENNON Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2008
Decision Date	05/06/2008
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