FDA 510(k) Application Details - K100152

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K100152
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 BENSHEIM D-64625 DE Other 510(k) Applications for this Company
Contact	FRITZ KOLLE 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	01/19/2010
Decision Date	10/22/2010
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