FDA 510(k) Application Details - K150909

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K150909
Device Name	Unit, Operative Dental
Applicant	Sirona Dental Systems GMBH Fabrikstrasse 31 Bensheim 64625 DE Other 510(k) Applications for this Company
Contact	Thomas Diesch Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2015
Decision Date	07/17/2015
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