FDA 510(k) Application Details - K130140

Device Classification Name Implant, Endosseous, Root-Form

  More FDA Info for this Device
510(K) Number K130140
Device Name Implant, Endosseous, Root-Form
Applicant INTRA-LOCK INTERNATIONAL
6560 WEST ROGERS CIRCLE
SUITE 24
BOCA RATON, FL 33487 US
Other 510(k) Applications for this Company
Contact DIANA TAYLOR
Other 510(k) Applications for this Contact
Regulation Number 872.3640

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

  More FDA Info for this Product Code
Date Received 01/22/2013
Decision Date 08/01/2013
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