FDA 510(k) Application Details - K031658

Device Classification Name Alloy, Amalgam

  More FDA Info for this Device
510(K) Number K031658
Device Name Alloy, Amalgam
Applicant SOUTHERN DENTAL INDUSTRIES, INC.
729 N. ROUTE 83, SUITE 315
BENSENVILLE, IL 60106 US
Other 510(k) Applications for this Company
Contact SAMANTHA J CHEETHAM
Other 510(k) Applications for this Contact
Regulation Number 872.3070

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

  More FDA Info for this Product Code
Date Received 05/28/2003
Decision Date 07/29/2003
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 N
Expedited Review



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