FDA 510(k) Application Details - K131014

Device Classification Name Handpiece, Air-Powered, Dental

  More FDA Info for this Device
510(K) Number K131014
Device Name Handpiece, Air-Powered, Dental
Applicant NSK AMERICA CORP.
1201 RICHARDSON DR.
SUITE 280
RICHARDSON, TX 75080 US
Other 510(k) Applications for this Company
Contact DIANE RUTHERFORD
Other 510(k) Applications for this Contact
Regulation Number 872.4200

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

  More FDA Info for this Product Code
Date Received 04/11/2013
Decision Date 08/12/2013
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