The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gc Fuji Triage Ep.
| Device ID | K193484 |
| 510k Number | K193484 |
| Device Name: | GC Fuji Triage EP |
| Classification | Cement, Dental |
| Applicant | GC America Inc. 3737 W. 127th Street Alsip, IL 60780 3 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC America Inc. 3737 W. 127th Street Alsip, IL 60780 3 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-07-02 |