FDA 510(k) Application Details - K032921

Device Classification Name Material, Tooth Shade, Resin

  More FDA Info for this Device
510(K) Number K032921
Device Name Material, Tooth Shade, Resin
Applicant SYBRON DENTAL SPECIALTIES, INC.
1717 W. 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 872.3690

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

  More FDA Info for this Product Code
Date Received 09/22/2003
Decision Date 11/13/2003
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