FDA 510(k) Application Details - K050647

Device Classification Name Agent, Tooth Bonding, Resin

  More FDA Info for this Device
510(K) Number K050647
Device Name Agent, Tooth Bonding, Resin
Applicant BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG, IL 60193 US
Other 510(k) Applications for this Company
Contact BENJAMIN LICHTENWALNER
Other 510(k) Applications for this Contact
Regulation Number 872.3200

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

  More FDA Info for this Product Code
Date Received 03/14/2005
Decision Date 04/20/2005
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