FDA 510(k) Application Details - K041272

Device Classification Name Cement, Dental

  More FDA Info for this Device
510(K) Number K041272
Device Name Cement, Dental
Applicant DENTSPLY INTL.
221 WEST PHILADELPHIA STREET
SUITE 60
YORK, PA 17404 US
Other 510(k) Applications for this Company
Contact P. JEFFERY LEHN
Other 510(k) Applications for this Contact
Regulation Number 872.3275

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

  More FDA Info for this Product Code
Date Received 05/12/2004
Decision Date 10/18/2004
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