FDA 510(k) Application Details - K030007

Device Classification Name Implant, Endosseous, Root-Form

  More FDA Info for this Device
510(K) Number K030007
Device Name Implant, Endosseous, Root-Form
Applicant STRAUMANN USA
RESERVOIR PLACE,
1601 TRAPELO ROAD
WALTHAM, MA 02154 US
Other 510(k) Applications for this Company
Contact LINDA JALBERT
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 01/01/2003
Decision Date 03/31/2003
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