FDA 510(k) Application Details - K080240

Device Classification Name Handpiece, Air-Powered, Dental

  More FDA Info for this Device
510(K) Number K080240
Device Name Handpiece, Air-Powered, Dental
Applicant PROMIDENT LLC
242 NORTH MAIN ST.
NEW CITY, NY 10956 US
Other 510(k) Applications for this Company
Contact GARY KRIS
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 01/31/2008
Decision Date 02/07/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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