The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gc Fujicem 2 (improved).
| Device ID | K182854 |
| 510k Number | K182854 |
| Device Name: | GC FujiCEM 2 (Improved) |
| Classification | Cement, Dental |
| Applicant | GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-10 |
| Decision Date | 2019-07-11 |