FDA 510(k) Application Details - K093643

Device Classification Name Abutment, Implant, Dental, Endosseous

  More FDA Info for this Device
510(K) Number K093643
Device Name Abutment, Implant, Dental, Endosseous
Applicant NOBELBIOCARE AB
22715 SAVI RANCH PARKWAY
YORBA LINDA, CA 92887 US
Other 510(k) Applications for this Company
Contact HERBERT CRANE
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 11/25/2009
Decision Date 06/24/2010
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



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