FDA 510(k) Application Details - K062506

Device Classification Name Powder, Porcelain

  More FDA Info for this Device
510(K) Number K062506
Device Name Powder, Porcelain
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 872.6660

  More FDA Info for this Regulation Number
Classification Product Code EIH
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/28/2006
Decision Date 09/08/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact