GC Fuji Direct
Cement, Dental
GC America Inc.
The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gc Fuji Direct.
Pre-market Notification Details
| Device ID | K172382 |
| 510k Number | K172382 |
| Device Name: | GC Fuji Direct |
| 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 | 2017-08-08 |
| Decision Date | 2018-04-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10386040012522 | K172382 | 000 |
| 10386040012515 | K172382 | 000 |
| 10386040012508 | K172382 | 000 |
| 14548161321983 | K172382 | 000 |
| 14548161321976 | K172382 | 000 |
| 14548161321969 | K172382 | 000 |
Trademark Results [GC Fuji Direct]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC FUJI DIRECT 86575463 not registered Dead/Abandoned |
Trademark Holdings of Illinois LLC 2015-03-25 |
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