FDA 510(k) Application Details - K982576

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K982576
Device Name	Implant, Endosseous, Root-Form
Applicant	FRIATEC AG ONE AMERICA PLAZA 600 WEST BROADWAY, SUITE 900 SAN DIEGO, CA 92101 US Other 510(k) Applications for this Company
Contact	EUGENE GOORCHENKO 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	07/24/1998
Decision Date	10/22/1998
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