The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gradia Forte.
| Device ID | K080478 |
| 510k Number | K080478 |
| Device Name: | GRADIA FORTE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-22 |
| Decision Date | 2008-06-05 |