FDA 510(k) Application Details - K001048

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

  More FDA Info for this Device
510(K) Number K001048
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant RELIANCE ORTHODONTIC PRODUCTS, INC.
1100 W. IRVING PARK RD.
SCHAUMBURG, IL 60193 US
Other 510(k) Applications for this Company
Contact KATHRYN B PATTERSON
Other 510(k) Applications for this Contact
Regulation Number 872.3750

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

  More FDA Info for this Product Code
Date Received 03/23/2000
Decision Date 04/27/2000
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