FDA 510(k) Application Details - K124008

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K124008
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	IVOCLAR VIVADENT, AGIN 175 PINEVIEW DRIVE AMHERST, NY 14228 US Other 510(k) Applications for this Company
Contact	DONNA MARIE HARTNETT 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	12/27/2012
Decision Date	03/29/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review