G-CEM ONE
Cement, Dental
GC America Inc.
The following data is part of a premarket notification filed by Gc America Inc. with the FDA for G-cem One.
Pre-market Notification Details
| Device ID | K200798 |
| 510k Number | K200798 |
| Device Name: | G-CEM ONE |
| 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 | 2020-03-26 |
| Decision Date | 2020-11-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470136761 | K200798 | 000 |
| 04548161300400 | K200798 | 000 |
| 04548161300417 | K200798 | 000 |
| 04548161300424 | K200798 | 000 |
| 04548161300431 | K200798 | 000 |
| 04548161300448 | K200798 | 000 |
| 04548161300455 | K200798 | 000 |
| 04548161322037 | K200798 | 000 |
| 04548161396250 | K200798 | 000 |
| D0470136421 | K200798 | 000 |
| D0470136701 | K200798 | 000 |
| D0470136711 | K200798 | 000 |
| D0470136721 | K200798 | 000 |
| D0470136731 | K200798 | 000 |
| D0470136741 | K200798 | 000 |
| D0470136751 | K200798 | 000 |
| 04548161300394 | K200798 | 000 |
Trademark Results [G-CEM ONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 G-CEM ONE 79295307 not registered Live/Pending |
GC Corporation 2020-08-07 |
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