FDA 510(k) Application Details - K082800

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K082800
Device Name	Implant, Endosseous, Root-Form
Applicant	PARK DENTAL RESEARCH CORP. 5335 WISCONSIN AVE. NW SUITE 440 WASHINGTON, DC 20015 US Other 510(k) Applications for this Company
Contact	DANIEL J MANELLI Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2008
Decision Date	08/26/2010
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