FDA 510(k) Application Details - K012720

Device Classification Name Handpiece, Air-Powered, Dental

  More FDA Info for this Device
510(K) Number K012720
Device Name Handpiece, Air-Powered, Dental
Applicant DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK, PA 17405-0872 US
Other 510(k) Applications for this Company
Contact P. JEFFREY LEHN
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 08/15/2001
Decision Date 11/08/2001
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