FDA 510(k) Application Details - K052957

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K052957
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	DENTIUM CO., LTD. 5536 TROWBRIDGE DRIVE DUNWOODY, GA 30338 US Other 510(k) Applications for this Company
Contact	CATHRYN N CAMBRIA 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	10/21/2005
Decision Date	07/27/2006
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