FDA 510(k) Application Details - K032892

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

  More FDA Info for this Device
510(K) Number K032892
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant DENTSPLY INTL.
570 WEST COLLEGE AVENUE
YORK, PA 17404 US
Other 510(k) Applications for this Company
Contact P. JEFFERY LEHN
Other 510(k) Applications for this Contact
Regulation Number 872.3760

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

  More FDA Info for this Product Code
Date Received 09/17/2003
Decision Date 09/26/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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