FDA 510(k) Application Details - K103234

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K103234
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	GC AMERICA, INC. 10 E. SCRANTON AVENUE SUITE 201 LAKE BLUFF, IL 60044 US Other 510(k) Applications for this Company
Contact	CARL JENKINS 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	11/02/2010
Decision Date	06/30/2011
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