The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fuji Ortho Band Paste Pak.
| Device ID | K020578 |
| 510k Number | K020578 |
| Device Name: | GC FUJI ORTHO BAND PASTE PAK |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz |
| Correspondent | Terry L Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-21 |
| Decision Date | 2002-04-26 |