FDA 510(k) Application Details - K083669

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K083669
Device Name	Implant, Endosseous, Root-Form
Applicant	EUROTEKNIKA 1100 RENE-LEVESQUE-BLVD WEST -25TH FLOOR MONTREAL, QUEBEC H3B 5C9 CA Other 510(k) Applications for this Company
Contact	EMMANUEL MONTINI 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	12/11/2008
Decision Date	06/08/2009
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