The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Light Bond (quick Cure).
Device ID | K001048 |
510k Number | K001048 |
Device Name: | LIGHT BOND (QUICK CURE) |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | RELIANCE ORTHODONTIC PRODUCTS, INC. 1100 W. IRVING PARK RD. Schaumburg, IL 60193 |
Contact | Kathryn B Patterson |
Correspondent | Kathryn B Patterson RELIANCE ORTHODONTIC PRODUCTS, INC. 1100 W. IRVING PARK RD. Schaumburg, IL 60193 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-23 |
Decision Date | 2000-04-27 |