FDA 510(k) Application Details - K132067

Device Classification Name Abutment, Implant, Dental, Endosseous

  More FDA Info for this Device
510(K) Number K132067
Device Name Abutment, Implant, Dental, Endosseous
Applicant HIOSSEN INC.
85 BEN FAIRLESS DRIVE
FAIRLESS HILLS, PA 19030 US
Other 510(k) Applications for this Company
Contact PATRICK LIM
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 07/03/2013
Decision Date 12/20/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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