FDA 510(k) Application Details - K122039

Device Classification Name Crown And Bridge, Temporary, Resin

  More FDA Info for this Device
510(K) Number K122039
Device Name Crown And Bridge, Temporary, Resin
Applicant KETTENBACH GMBH & CO KG
IM HEERFELD 7
ESCHENBURG 35713 DE
Other 510(k) Applications for this Company
Contact JUERGEN BERGER
Other 510(k) Applications for this Contact
Regulation Number 872.3770

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

  More FDA Info for this Product Code
Date Received 07/11/2012
Decision Date 12/27/2012
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



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