FDA 510(k) Application Details - K030646

Device Classification Name Coating, Filling Material, Resin

  More FDA Info for this Device
510(K) Number K030646
Device Name Coating, Filling Material, Resin
Applicant KERR DENTAL MATERIALS CENTER
1717 WEST COLLINS AVE.
ORANGE, CA 92867 US
Other 510(k) Applications for this Company
Contact COLLEEN BOSWELL
Other 510(k) Applications for this Contact
Regulation Number 872.3310

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

  More FDA Info for this Product Code
Date Received 02/28/2003
Decision Date 05/06/2003
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